FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
95641–95664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1996
EXACTECH ALL POLY ACETABULAR CUP
K963313 · JDI
Exactech, Inc.
Orthopedic · 84d
Cleared Nov 14, 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · HWC
Depuy, Inc.
Orthopedic · 80d
Cleared Nov 14, 1996
OSTEOMED TRAM
K963394 · JEY
Osteomed Corp.
Dental · 78d
Cleared Nov 14, 1996
POSEY HUGGER
K963409 · FMQ
J. T. Posey Co.
General Hospital · 76d
Cleared Nov 14, 1996
MULTIPLE LIMB HOLDERS
K963413 · FMQ
J. T. Posey Co.
General Hospital · 76d
Cleared Nov 14, 1996
MITTENS
K963469 · FMQ
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
CRISS-CROSS VEST RESTRAINT
K963470 · FMQ
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
SUPER SECURITY RESTRAINT
K963471 · FMQ
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
PEDIATRIC VEST RESTRAINT
K963472 · FMQ
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
REUSABLE LIMB HOLDER
K963473 · FMQ
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
SLEEVED/SLEEVELESS VEST RESTRAINT
K963478 · FMQ
Deroyal Industries, Inc.
General Hospital · 72d
Cleared Nov 14, 1996
STUCKEY STRAP-3 FINGER RESTRAINTS
K963491 · FMQ
Stuckey Ent., Inc.
General Hospital · 72d
Cleared Nov 14, 1996
KSEA LARGE JOINT ARTHROSCOPY SET
K963524 · HRX
Karl Storz Endoscopy
Orthopedic · 71d
Cleared Nov 14, 1996
PHASE PLUS
K963609 · ELW
Zhermack S.P.A.
Dental · 65d
Cleared Nov 14, 1996
ACROMED PEDICLE SCREW
K963639 · KWP
Acromed Corp.
Orthopedic · 63d
Cleared Nov 14, 1996
BME BONE DRILL BITS
K964073 · GEY
Biomedical Ent., Inc.
General & Plastic Surgery · 34d
Cleared Nov 13, 1996
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520 · LDF
Medtronic Vascular
Cardiovascular · 205d
Cleared Nov 13, 1996
KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
K961605 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 202d
Cleared Nov 13, 1996
PES HOT/COLD COMPRESS
K962038 · IRT
Princeton Electronic Systems, Inc.
Physical Medicine · 173d
Cleared Nov 13, 1996
EZ-FIX CANNULATED SCREW SYSTEM
K962706 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 124d
Cleared Nov 13, 1996
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
K962821 · CAZ
Global Medical Products, Ltd.
Anesthesiology · 117d
Cleared Nov 13, 1996
ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39
K963193 · GEX
Transamerican Technologies Intl.
General & Plastic Surgery · 90d
Cleared Nov 13, 1996
VAIL 100 PEDIATRIC CRIB
K963210 · FMS
Vail Products, Inc.
General Hospital · 89d
Cleared Nov 13, 1996
CORDIS ST STEERABLE GUIDEWIRE
K963214 · DQX
Cordis Corp.
Cardiovascular · 89d