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
43849–43872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2012
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON
K112790 · LPS
Axis-Shield Diagnostics, Ltd.
Chemistry · 224d
Cleared May 07, 2012
GEN_2 MECHANICAL WHEELCHAIR
K113713 · IOR
Free Wheelchair Mission
Physical Medicine · 140d
Cleared May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW,...
K113732 · JAK
Brainlab AG
Radiology · 140d
Cleared May 07, 2012
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM
K120106 · MUH
Apixia, Inc.
Radiology · 115d
Cleared May 07, 2012
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
K120550 · DQK
Biosense Webster, Inc.
Cardiovascular · 74d
Cleared May 07, 2012
PIONEER LATERAL PLATE SYSTEM
K120724 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 59d
Cleared May 04, 2012
QUANTUM DENTAL IMPLANT SYSTEM
K112279 · DZE
Quantum Bioengineering, Ltd.
Dental · 269d
Cleared May 04, 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE...
K112549 · FRO
Covalontechnologies, Inc.
General & Plastic Surgery · 246d
Cleared May 04, 2012
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
K112665 · EKX
J. Morita USA, Inc.
Dental · 234d
Cleared May 04, 2012
STERILCONTAINER SYSTEM
K112671 · KCT
Aesculap, Ltd.
General Hospital · 233d
Cleared May 04, 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · LIT
Cordis Corp.
Cardiovascular · 221d
Cleared May 04, 2012
KIMBERLY-CLARK CHILD'S FACEMASK
K113340 · OXZ
Kimberly-Clark
General Hospital · 172d
Cleared May 04, 2012
DUKAL LUBRICATING JELLY
K113689 · KMJ
Dukal Corporation
General Hospital · 141d
Cleared May 04, 2012
VIVIX-S
K120020 · MQB
Vieworks Co., Ltd.
Radiology · 122d
Cleared May 04, 2012
KENSEY NASH BONE VOID FILLER XC
K120141 · MQV
Kensey Nash Cororation
Orthopedic · 107d
Cleared May 04, 2012
ACCUSONIC ADVANTAGE
K120171 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 105d
Cleared May 04, 2012
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
K120362 · LZO
Corin USA
Orthopedic · 88d
Cleared May 04, 2012
UNIMED DISPOSABLE BLOOD PRESSURE CUFF
K120364 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 88d
Cleared May 04, 2012
UNITED U2 FEMORAL COMPONENT, PS, #7
K120507 · JWH
United Orthopedic Corporation
Orthopedic · 73d
Cleared May 04, 2012
END TIDAL CO2 NASAL CANNULA
K120518 · CCK
Care Fusion
Anesthesiology · 73d
Cleared May 04, 2012
HLIC NEEDLE-LESS VALVE
K120548 · FPA
Health Line International Corporation
General Hospital · 71d
Cleared May 04, 2012
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
K121015 · NTE
Abbott Vascular
Cardiovascular · 30d
Cleared May 04, 2012
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
K121057 · DTK
William Cook Europe Aps
Cardiovascular · 28d
Cleared May 03, 2012
FORCE MEDICAL IM NAIL SYSTEM
K102577 · HSB
Force Medical, Inc.
Orthopedic · 603d