TPLC - Total Product Life Cycle

• Device: electrosurgical, cutting & coagulation & accessories
• Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
• Product Code: GEI
• Regulation Number: 878.4400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADEOR MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
AERIN MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
AERIN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
AERIN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP INC.
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESTHETIC MANAGEMENT PARTNERS
	SUBSTANTIALLY EQUIVALENT	1
AESTHETICS BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AGENCY FOR MEDICAL INNOVATIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1
AGNES MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
ALIC IOTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
ALMA LASERS INC.
	SUBSTANTIALLY EQUIVALENT	1
APPLIED MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	5
APPLIED MEDICAL RESOURCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
APYX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
APYX MEDICAL CORPORATION (FORMERLY BOVIE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
APYX MEDICAL CORPORATION(FORMERLY BOVIE MEDICAL CORPORATION)
	SUBSTANTIALLY EQUIVALENT	2
ARTHROCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
AUCKLAND MEDICAL POLYMER(TIANJIN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AUGUSTINE TEMPERATURE MANAGEMENT LLC
	SUBSTANTIALLY EQUIVALENT	1
AXON SPINE MEDICAL SYSTEM
	SUBSTANTIALLY EQUIVALENT	1
BAISHENG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BAISHENG MEDICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL COMPANY INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
BIPAD SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOLDER SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	4
BOLDER SURGICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
BOVIE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
BOVIE MEDICAL CORPORATION DBA APYX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
BOWA-ELECTRONICS GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
BRERA MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
BRONCUS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
BTL
	SUBSTANTIALLY EQUIVALENT	3
BTL INDUSTRIES INC.
	SUBSTANTIALLY EQUIVALENT	5
BTL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
C2DX, INC.
	SUBSTANTIALLY EQUIVALENT	1
CAMBRIDGE INTERVENTIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CAREFUSION 2200 INC
	SUBSTANTIALLY EQUIVALENT	1
CARTESSA AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
CATHAY MANFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
CHUNGWOO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CLASSYS INC.
	SUBSTANTIALLY EQUIVALENT	1
CNC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
COMPAL ELECTRONICS, INC
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	6
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	8
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	5
CROSS VASCULAR INC.
	SUBSTANTIALLY EQUIVALENT	1
CUTERA INC.
	SUBSTANTIALLY EQUIVALENT	2
CYNOSURE LLC
	SUBSTANTIALLY EQUIVALENT	1
CYNOSURE, INC
	SUBSTANTIALLY EQUIVALENT	3
CYNOSURE, LLC
	SUBSTANTIALLY EQUIVALENT	1
DANNIK
	SUBSTANTIALLY EQUIVALENT	2
DANNIK LLC
	SUBSTANTIALLY EQUIVALENT	2
DELTRONIX EQUIPAMENTOS LTDA
	SUBSTANTIALLY EQUIVALENT	1
DEX SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
E SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELLIQUENCE LLC
	SUBSTANTIALLY EQUIVALENT	1
ELLIQUENCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELLUSA, LLC
	SUBSTANTIALLY EQUIVALENT	4
ENCISION INC.
	SUBSTANTIALLY EQUIVALENT	1
ENCISION INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
ENERGIST LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	6
ETHICON ENDO-SURGERY
	SUBSTANTIALLY EQUIVALENT	1
ETHICON ENDO-SURGERY, LLC
	SUBSTANTIALLY EQUIVALENT	8
EXCELSIOR RESOURCES LLC
	SUBSTANTIALLY EQUIVALENT	1
F CARE SYSTEMS USA LLC
	SUBSTANTIALLY EQUIVALENT	1
FAULHABER PINZETTEN OHG
	SUBSTANTIALLY EQUIVALENT	1
FHC, INC.
	SUBSTANTIALLY EQUIVALENT	1
FULWELL LLC
	SUBSTANTIALLY EQUIVALENT	2
GENICON, INC
	SUBSTANTIALLY EQUIVALENT	1
GENICON, INC.
	SUBSTANTIALLY EQUIVALENT	1
GETSCH+HILLER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
GMV S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
GOWOONSESANG COSMETICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
GUENTER BISSINGER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
GUNTER BISSINGER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI INC.
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
HG INNOVATIONS LTD
	SUBSTANTIALLY EQUIVALENT	3
HIRONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HIRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOOGLAND SPINE PRODUCTS, GMBH
	SUBSTANTIALLY EQUIVALENT	1
HS HOSPITAL SERVICE SPA
	SUBSTANTIALLY EQUIVALENT	2
HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ILOODA CO., LTD
	SUBSTANTIALLY EQUIVALENT	3
ILOODA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INMODE LTD.
	SUBSTANTIALLY EQUIVALENT	7
INMODE MD LTD.
	SUBSTANTIALLY EQUIVALENT	5
INNOBLATIVE DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA MICROFRANCE
	SUBSTANTIALLY EQUIVALENT	1
INTELIS INSTRUMENTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTUITIVE SURGICAL
	SUBSTANTIALLY EQUIVALENT	4
INVUITY INC.
	SUBSTANTIALLY EQUIVALENT	1
ITALIAN ENGINEERING SRL
	SUBSTANTIALLY EQUIVALENT	1
JAC-CELL MEDIC
	SUBSTANTIALLY EQUIVALENT	1
JACO, LLC DBA MACAN MANUFACTURING AND BNA BURZ NORTH AMERICA
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
JEISYS MEDICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
JEISYS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HOPE BIOMEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU HOPE BIOMEDICAL SCIENCE&TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU RONG FU KANG MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KATALYST SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
KIRWAN SURGICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
KLS MARTIN GMBH + CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LED SPA
	SUBSTANTIALLY EQUIVALENT	1
LEXINGTON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	2
LIVSMED INC.
	SUBSTANTIALLY EQUIVALENT	9
LUMENDI, LLC
	SUBSTANTIALLY EQUIVALENT	2
LUTRONIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CARDIOVASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CARDIOVASCULAR, LLC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTIRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
MEDRANGE
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC ADVANCED ENERGY
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	3
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MICROLINE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD.
	SUBSTANTIALLY EQUIVALENT	4
NEAUVIA NORTH AMERICA, INC
	SUBSTANTIALLY EQUIVALENT	3
NEURENT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
NEW DEANTRONICS TAIWAN, LTD
	SUBSTANTIALLY EQUIVALENT	1
NEW DEANTRONICS TAIWAN LTD
	SUBSTANTIALLY EQUIVALENT	7
NEW DEANTRONICS TAIWAN, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NICO CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
NINGBO SHUN YE MEDICAL COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NISSHA MEDICAL TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
NOVOXEL LTD.
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	7
PAVMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLLOGEN LTD
	SUBSTANTIALLY EQUIVALENT	1
POLLOGEN LTD.
	SUBSTANTIALLY EQUIVALENT	4
PRECISION SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
PULSE BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	7
REBOUND THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	4
RELIGN CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
RELIGN CORPORATION, SUBSIDIARY OF ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1
RF MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ROHRER AESTHETICS
	SUBSTANTIALLY EQUIVALENT	1
ROHRER AESTHETICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SAFER SURGERIES MEDICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SCITON, INC.
	SUBSTANTIALLY EQUIVALENT	1
SEJONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENB CO LTD
	SUBSTANTIALLY EQUIVALENT	5
SHENB CO LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHINING WORLD HEALTH CARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SINGLE PASS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOLTA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
SONIQUENCE, LLC
	SUBSTANTIALLY EQUIVALENT	5
SPIRATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
STARMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	7
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	3
SURGICAL DIRECT, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL PRINCIPALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL TECHNOLOGY LABORATORIES, INC
	SUBSTANTIALLY EQUIVALENT	1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SURNIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SUTTER MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	5
SYNERON MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TENTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
THERMGEN, L.L.C
	SUBSTANTIALLY EQUIVALENT	1
THERMI
	SUBSTANTIALLY EQUIVALENT	1
THERMIGEN, L.L.C
	SUBSTANTIALLY EQUIVALENT	1
TITAN MANUFACTURING, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRIWORKS GROUP SRL
	SUBSTANTIALLY EQUIVALENT	2
UNITED STATES ENDOSCOPY GROUP, INC
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES ENDOSCOPY GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
US ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
US MEDICAL INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
VENCLOSE, INC.
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	3
VHMED (NANTONG) CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
VIOL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
VIVEVE INC.
	SUBSTANTIALLY EQUIVALENT	1
VIVEVE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VIVEVE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
VIVEVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WON TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	6069	6069
2018	6545	6545
2019	7066	7066
2020	6490	6490
2021	6351	6351
2022	6103	6103
2023	7177	7177
2024	5544	5544

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	8019	8019
Adverse Event Without Identified Device or Use Problem	5132	5132
Energy Output Problem	3151	3151
Detachment of Device or Device Component	2650	2650
Difficult to Open or Close	2528	2528
Peeled/Delaminated	1893	1893
Electrical /Electronic Property Problem	1820	1820
Output Problem	1263	1263
Self-Activation or Keying	1124	1124
Insufficient Information	1044	1044
Device Displays Incorrect Message	1028	1028
Material Separation	967	967
Sparking	861	861
Retraction Problem	835	835
Mechanical Problem	835	835
Fire	831	831
Material Twisted/Bent	811	811
Failure to Deliver Energy	802	802
Melted	770	770
Delivered as Unsterile Product	761	761
Detachment Of Device Component	697	697
Material Fragmentation	677	677
Failure to Cut	677	677
Energy Output To Patient Tissue Incorrect	665	665
Overheating of Device	624	624
Activation Problem	621	621
Protective Measures Problem	591	591
Device Alarm System	554	554
Connection Problem	518	518
Application Program Problem: Parameter Calculation Error	508	508
Use of Device Problem	506	506
Appropriate Term/Code Not Available	505	505
Infusion or Flow Problem	494	494
Device Operates Differently Than Expected	484	484
Smoking	484	484
Arcing	469	469
Device Remains Activated	465	465
Mechanical Jam	459	459
Electrical Shorting	411	411
Material Integrity Problem	410	410
No Apparent Adverse Event	399	399
Fracture	387	387
Defective Device	382	382
Temperature Problem	381	381
Communication or Transmission Problem	334	334
Intermittent Energy Output	312	312
Material Deformation	309	309
Suction Failure	290	290
Thermal Decomposition of Device	274	274
Unintended Power Up	250	250

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19784	19784
No Consequences Or Impact To Patient	12879	12880
No Known Impact Or Consequence To Patient	5419	5419
Burn(s)	2432	2433
No Patient Involvement	1897	1897
Insufficient Information	1869	1869
Hemorrhage/Bleeding	1491	1491
No Information	1141	1141
Partial thickness (Second Degree) Burn	643	643
Superficial (First Degree) Burn	583	583
No Code Available	580	580
Blood Loss	565	565
Foreign Body In Patient	548	548
Full thickness (Third Degree) Burn	324	324
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	317	317
Injury	309	309
Burn, Thermal	302	302
Pain	293	293
Unspecified Tissue Injury	238	238
Not Applicable	215	215
Hematoma	212	212
Erythema	196	196
Device Embedded In Tissue or Plaque	184	184
Blister	159	159
Unspecified Infection	156	156
Tissue Damage	151	151
Patient Problem/Medical Problem	130	130
Bowel Perforation	126	126
Scar Tissue	124	124
Electric Shock	123	123
Skin Discoloration	117	117
Perforation	100	100
Death	82	82
Necrosis	78	78
Stenosis	72	72
Thrombosis/Thrombus	70	70
Laceration(s)	69	69
Inflammation	68	68
Abscess	68	68
Fistula	67	67
Nerve Damage	58	58
Fever	58	58
Swelling/ Edema	56	56
Pneumothorax	54	54
Bowel Burn	52	52
Skin Inflammation/ Irritation	51	51
Post Operative Wound Infection	51	51
Shock	47	47
Abdominal Pain	46	46
Thrombus	46	46

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	May-05-2023
2	Aesculap Implant Systems LLC	II	Sep-09-2019
3	Aesculap Implant Systems LLC	II	Feb-16-2017
4	Angiodynamics Inc. (Navilyst Medical Inc.)	II	Nov-15-2019
5	Aomori Olympus Co., Ltd.	II	Feb-05-2021
6	Applied Medical Resources Corp	II	Nov-21-2019
7	Beaver Visitec International, Inc.	II	Jun-23-2022
8	Beaver-Visitec International Inc.	II	May-10-2018
9	Beaver-Visitec International Inc.	II	Apr-27-2018
10	Bolder Surgical, LLC	II	Mar-08-2022
11	Boston Scientific Corporation	II	Dec-22-2020
12	Bovie Medical Corporation	II	Feb-26-2021
13	Bovie Medical Corporation	II	May-20-2020
14	Bovie Medical Corporation	II	Oct-19-2018
15	Bovie Medical Corporation	II	Mar-21-2018
16	COVIDIEN MEDTRONIC	II	Apr-18-2017
17	Carefusion 2200 Inc	II	Dec-03-2022
18	ConMed Corporation	II	Dec-09-2022
19	ConMed Corporation	II	Apr-07-2017
20	CooperSurgical, Inc.	II	Jun-10-2021
21	CooperSurgical, Inc.	III	Sep-16-2019
22	Covidien	II	Jan-03-2024
23	Covidien	II	Apr-12-2021
24	Covidien Llc	II	Jan-13-2022
25	Covidien Llc	II	Feb-25-2020
26	Covidien, PLC	II	Mar-18-2019
27	Dannoritzer Medizintechnik GmbH & Co. KG	III	Oct-03-2018
28	DeRoyal Industries Inc	II	May-01-2018
29	Ethicon Endo-Surgery Inc	II	Jun-26-2019
30	Gyrus ACMI, Inc.	II	Apr-17-2019
31	Integra LifeSciences Corp.	II	Aug-07-2019
32	Intuitive Surgical, Inc.	II	May-31-2022
33	Invuity, Inc.	II	Jul-28-2017
34	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
35	Maquet Cardiovascular, LLC	II	Jul-11-2024
36	Maquet Cardiovascular, LLC	II	Jun-24-2024
37	Maquet Cardiovascular, LLC	II	Jan-12-2024
38	Maquet Cardiovascular, LLC	II	Nov-02-2023
39	Maquet Cardiovascular, LLC	II	Apr-04-2023
40	Maquet Cardiovascular, LLC	II	Jan-19-2023
41	Maquet Cardiovascular, LLC	II	Mar-14-2017
42	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
43	Mederi Therapeutics, Inc	II	May-08-2017
44	Megadyne Medical Products, Inc.	I	Jul-03-2024
45	Megadyne Medical Products, Inc.	I	Jun-06-2024
46	Megadyne Medical Products, Inc.	I	Dec-26-2023
47	Megadyne Medical Products, Inc.	II	Jul-28-2023
48	Megadyne Medical Products, Inc.	I	Jun-30-2023
49	Megadyne Medical Products, Inc.	II	Aug-13-2018
50	Microline Surgical, Inc.	II	Jun-01-2019
51	Microline Surgical, Inc.	II	May-08-2018
52	Microline Surgical, Inc.	II	Feb-02-2018
53	Nico Corp.	II	Jun-09-2021
54	Olsen Medical	II	May-25-2018
55	Olympus Corporation of the Americas	II	Aug-08-2024
56	Olympus Corporation of the Americas	II	Jul-23-2024
57	Olympus Corporation of the Americas	II	Apr-30-2024
58	Olympus Corporation of the Americas	II	Feb-20-2024
59	Olympus Corporation of the Americas	II	Sep-26-2022
60	Olympus Corporation of the Americas	II	Aug-27-2021
61	Solta Medical Inc	II	Apr-07-2023
62	Solta Medical Inc	II	Apr-07-2020
63	Steris Corporation	II	Nov-16-2022
64	Stryker Corporation	II	Nov-07-2023
65	Stryker Corporation	II	Mar-17-2020
66	Stryker Instruments Div. of Stryker Corporation	II	Apr-28-2020
67	Stryker Instruments Div. of Stryker Corporation	II	Jan-28-2020
68	Sutter Medizintechnik GmbH	II	Jul-31-2020
69	Teleflex Medical	II	Jan-18-2019
70	Teleflex Medical	II	Oct-31-2017
71	Teleflex Medical	II	Sep-27-2017
72	Terumo Cardiovascular Systems Corporation	II	Oct-24-2018
73	Xodus Medical Inc	II	Oct-16-2019