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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 500 Results *
Date Classified to: 07/04/2014 510(K) Number: K101558
 
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Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facili... 2 Apr-20-2015 Biomet Spine, LLC
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterio... 2 Apr-20-2015 Biomet Spine, LLC
Fluid Management System P4000, one unit per package; Serial numbers 20100001 through 20140044 2 Apr-20-2015 Thermedx LLC
Catalog Number B01-4840-01 REF: 01984894 2 Apr-20-2015 Siemens Healthcare Diagnostics, Inc.
DiaSorin, PRO-Trac" II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac ... 2 Apr-20-2015 Diasorin Inc.
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 70... 2 Apr-20-2015 Del Mar Reynolds Medical, Ltd.
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44 Product Usage: Humeral Heads are int... 2 Apr-20-2015 Exactech, Inc.
DBX Mix, 20 cc Prod Code: 058200 Aseptically packaged in a sterilized glass jar with a screw top l... 2 Apr-17-2015 Musculoskeletal Transplant Foundation, Inc.
STRATIFY JCV DxSelect, Model No. EL1950 2 Apr-17-2015 Focus Diagnostics Inc
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke -... 2 Apr-16-2015 CooperSurgical, Inc.

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