HWE · Class I · 21 CFR 878.4820

FDA Product Code HWE: Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

Leading manufacturers include U.S. Medical Products, Inc., Stryker Corp. and United American Medical Co., Inc..

76
Total
76
Cleared
110d
Avg days
1976
Since
76 devices
49–72 of 76
Cleared Jan 21, 1994
SODEM POWER SYSTEM
K935567
Sodemsystems
Orthopedic · 64d
Cleared Jan 07, 1994
OSTEON ADAPTOR/CRADLE
K930319
United American Medical Co., Inc.
Orthopedic · 350d
Cleared Jan 07, 1994
POWERED SURGICAL INSTRUMENT ACCESSORY
K930363
Intenn Engineering, Inc.
Orthopedic · 346d
Cleared Jan 07, 1994
ACUFEX STERILE DRILLS
K931837
Acufex Microsurgical, Inc.
Orthopedic · 269d
Cleared Jan 07, 1994
ES-100 ACCESSORIES
K932261
Elekta Instruments, Inc.
Orthopedic · 262d
Cleared Sep 18, 1992
HHI ELECTRIC CONSOLE #875-000
K922056
H&H Instruments
Orthopedic · 137d
Cleared Jun 08, 1992
CKS OSCILLATING SAW BLADE
K921131
Techmedica, Inc.
Orthopedic · 90d
Cleared Jul 02, 1991
SMALL BONE FIXATION SYSTEM
K911929
United American Medical Co., Inc.
Orthopedic · 63d
Cleared Jul 02, 1991
STERILE PACKAGED POWER INSTRUMENT ACCESSORIES
K911930
United American Medical Co., Inc.
Orthopedic · 63d
Cleared Nov 26, 1990
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
K902525
Buckman Co., Inc.
Orthopedic · 174d
Cleared Sep 14, 1990
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K903650
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 32d
Cleared Aug 14, 1990
CORING NEEDLE (TREPHINE, ORTHOPEDIC)
K902447
Biomedtrix, Ltd.
Orthopedic · 74d
Cleared Jun 25, 1990
HALL MODULAR ACETABULAR REAMER SYSTEM
K902332
Zimmer, Inc.
Orthopedic · 32d
Cleared Jun 13, 1990
MODULAR FLEXIBLE DRILLING SYSTEM
K901165
Dalton Technology, Inc.
Orthopedic · 92d
Cleared Sep 15, 1989
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 10, 1988
ACE SCREW REMOVAL TREPHINE
K882008
Buckman Co., Inc.
Orthopedic · 28d
Cleared Mar 04, 1988
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
K880150
Dyonics, Inc.
Orthopedic · 51d
Cleared Oct 15, 1987
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044
Medline Industries, Inc.
Orthopedic · 10d
Cleared Jun 05, 1987
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K871717
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 32d
Cleared Jan 28, 1987
HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
K864929
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 43d
Cleared Mar 04, 1986
3M ARTHROSCOPIC SURGICAL SYSTEM
K855216
3M Company
Orthopedic · 64d
Cleared Feb 11, 1986
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K854987
Richard Wolf Medical Instruments Corp.
Orthopedic · 61d
Cleared Nov 13, 1985
MORGAN SUTURE-DRILL
K853376
Bowen & Company, Inc.
Orthopedic · 93d
Cleared Sep 30, 1985
DEXTRA PRECISION POWER SYSTEM
K853489
Chattanooga Group, Inc.
Orthopedic · 41d