FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39481–39504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186 · HRS
Synthes USA Products, LLC
Orthopedic · 166d
Cleared Oct 08, 2013
COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
K131353 · PHX
Biomet Manufacturing Corp
Orthopedic · 151d
Cleared Oct 08, 2013
INMODE WMBODY DEVICE
K131362 · NUV
Inmode MD , Ltd.
General & Plastic Surgery · 148d
Cleared Oct 08, 2013
APEX KNEE MODULAR TIBIA SYSTEM
K131472 · JWH
Omni Life Science, Inc.
Orthopedic · 139d
Cleared Oct 08, 2013
INTEL-GE CARE INNOVATIONS QUIETCARE
K131585 · KMI
Intel-Ge Care Innovations, LLC
General Hospital · 130d
Cleared Oct 08, 2013
NERIA SOFT 90 INFUSION SET
K132142 · FPA
Unomedical A/S
General Hospital · 89d
Cleared Oct 08, 2013
UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES
K132224 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 83d
Cleared Oct 08, 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · OCW
Teleflexmedical, Inc.
General & Plastic Surgery · 70d
Cleared Oct 08, 2013
CD HORIZON SPINAL SYSTEM
K132471 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 62d
Cleared Oct 08, 2013
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
K132589 · KWQ
Life Spine, Inc.
Orthopedic · 50d
Cleared Oct 08, 2013
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND...
K132734 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Oct 08, 2013
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
K132829 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 29d
Cleared Oct 07, 2013
VISI MOBILE MONITORING SYSTEM
K130709 · MWI
Sotera Wireless, Inc.
Cardiovascular · 206d
Cleared Oct 07, 2013
KYMCO EQ20C SCOOTER
K130940 · INI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 186d
Cleared Oct 07, 2013
TRELLIS COLLAGEN RIBBON
K131143 · OWY
Wrightmedicaltechnologyinc
Orthopedic · 167d
Cleared Oct 07, 2013
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE...
K131201 · FGE
Cook, Inc.
Gastroenterology & Urology · 161d
Cleared Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · JJY
Helena Laboratories
Immunology · 138d
Cleared Oct 07, 2013
PHILIPS PIXIUM 4343RC
K131483 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 137d
Cleared Oct 07, 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 124d
Cleared Oct 07, 2013
HEM-6221
K131749 · DXN
Omron Healthcare, Inc.
Cardiovascular · 115d
Cleared Oct 07, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
K131769 · MBI
Pivot Medical, Inc.
Orthopedic · 112d
Cleared Oct 07, 2013
CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
K131771 · FLL
Thermomedics, Inc.
General Hospital · 112d
Cleared Oct 07, 2013
ESOFLIP BALLOON DILATION CATHETER
K132337 · PID
Crospon, Ltd.
Gastroenterology & Urology · 73d
Cleared Oct 07, 2013
ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
K133017 · GEI
Estech, Inc.
General & Plastic Surgery · 11d