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Panels › General, Plastic Surgery › Product code HWE · Class 1

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Regulation 878.4820

0510(k)s in 12 months (76 all time)
0recalls in 12 months (101 all time)
14recalls that name a 510(k)
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Top companies in HWE

Company510(k)sRecalls
Zimmer Biomet, Inc.059
Synthes (USA) Products LLC012
Stryker Instruments Div. of Stryker Corporation08
U.S. Medical Products, Inc.70
The Anspach Effort, Inc.14
Smith & Nephew, Inc., Endoscopy Div.04
Synthes (Usa)31
Richard Wolf Medical Instruments Corp.30
Stryker Corp.30
Synthes USA (HQ), Inc.03
Decided510(k)Device and applicantCode
Jan 7, 1994K931837ACUFEX STERILE DRILLS
Acufex Microsurgical, Inc.
HWE
Jan 7, 1994K930363POWERED SURGICAL INSTRUMENT ACCESSORY
Intenn Engineering, Inc.
HWE
Jan 7, 1994K930319OSTEON ADAPTOR/CRADLE
United American Medical Co., Inc.
HWE
Sep 18, 1992K922056HHI ELECTRIC CONSOLE #875-000
H&H Instruments
HWE
Jun 8, 1992K921131CKS OSCILLATING SAW BLADE
Techmedica, Inc.
HWE
Jul 2, 1991K911930STERILE PACKAGED POWER INSTRUMENT ACCESSORIES
United American Medical Co., Inc.
HWE
Jul 2, 1991K911929SMALL BONE FIXATION SYSTEM
United American Medical Co., Inc.
HWE
Nov 26, 1990K902525ACE/WILLIAMS MICROSURGERY SAW SYSTEM
Buckman Co., Inc.
HWE
Sep 14, 1990K903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
Micro-Aire Surgical Instruments, Inc.
HWE
Aug 14, 1990K902447CORING NEEDLE (TREPHINE, ORTHOPEDIC)
Biomedtrix, Ltd.
HWE
Jun 25, 1990K902332HALL MODULAR ACETABULAR REAMER SYSTEM
Zimmer, Inc.
HWE
Jun 13, 1990K901165MODULAR FLEXIBLE DRILLING SYSTEM
Dalton Technology, Inc.
HWE
Sep 15, 1989K895198HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
Zimmer, Inc.
HWE
Jun 10, 1988K882008ACE SCREW REMOVAL TREPHINE
Buckman Co., Inc.
HWE
Mar 4, 1988K880150PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
Dyonics, Inc.
HWE
Oct 15, 1987K874044INTRA-ARTICULAR ARTHROSCOPIC SHAVER
Medline Industries, Inc.
HWE
Jun 5, 1987K871717MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
KARL STORZ Endoscopy-America, Inc.
HWE
Jan 28, 1987K864929HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
Hall Surgical, Division of Zimmer, Inc.
HWE
Mar 4, 1986K8552163M ARTHROSCOPIC SURGICAL SYSTEM
3M Company
HWE
Feb 11, 1986K854987INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
Richard Wolf Medical Instruments Corp.
HWE
Nov 13, 1985K853376MORGAN SUTURE-DRILL
Bowen & Company, Inc.
HWE
Sep 30, 1985K853489DEXTRA PRECISION POWER SYSTEM
Chattanooga Group, Inc.
HWE
Dec 28, 1983K833940TORQUE PLUS CATALOG 30120
Concept, Inc.
HWE
Sep 16, 1980K802105C-BLADE
Cutter Laboratories, Inc.
HWE
Dec 27, 1979K792353INTRA-ARTICULATED EDGER-PLANER SYSTEM
Richard Wolf Medical Instruments Corp.
HWE
Nov 16, 1976K760977CHARNLEY FEMUR DRILL #1 AND #2
Codman & Shurtleff, Inc.
HWE

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