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
38113–38136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2014
SPHINX JR
K132975 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 176d
Cleared Mar 18, 2014
TINNITUS SOUNDSUPPORT
K133308 · KLW
Oticon A/S
Ear, Nose, Throat · 141d
Cleared Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
K133865 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 89d
Cleared Mar 18, 2014
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
K133894 · FPA
Terumo Europe N.V.
General Hospital · 88d
Cleared Mar 18, 2014
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA...
K140105 · OPX
The Binding Site
Immunology · 62d
Cleared Mar 17, 2014
SATURN DENTAL IMPLANT
K131258 · DZE
Cortex Dental Implants Industries , Ltd.
Dental · 319d
Cleared Mar 17, 2014
FORESEE (4C) IMAGING SYSTEM
K133209 · NQQ
Diagnostic Photonics, Inc.
General & Plastic Surgery · 151d
Cleared Mar 17, 2014
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH...
K134054 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 76d
Cleared Mar 14, 2014
EZ-OX PLUS GENERATION II
K131386 · ECX
Air Liquide Healthcare America
Anesthesiology · 304d
Cleared Mar 14, 2014
MANUKA FILL WOUND DRESSING
K131796 · FRO
Links Medical Products, Inc.
General & Plastic Surgery · 269d
Cleared Mar 14, 2014
SW-THERM
K131899 · IMJ
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 262d
Cleared Mar 14, 2014
FREND TSH (REAGENT CARTRIDGE)
K131928 · JLW
Nanoentek USA, Inc.
Chemistry · 260d
Cleared Mar 14, 2014
CERCOM II CEMENT
K132393 · EMA
Denali Corporation
Dental · 225d
Cleared Mar 14, 2014
FASTOUCH FIXATION SYSTEM
K132698 · GDW
Via Surgical , Ltd.
General & Plastic Surgery · 197d
Cleared Mar 14, 2014
BG MORSELS
K132805 · MQV
Prosidyan, Inc.
Orthopedic · 189d
Cleared Mar 14, 2014
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
K132944 · KPQ
Ge Hungary Kft
Radiology · 176d
Cleared Mar 14, 2014
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
K133227 · IYE
Varian Medical Systems, Inc.
Radiology · 144d
Cleared Mar 14, 2014
HEALTHINTERLINK BEACON
K133252 · DRG
Healthinterlink, LLC
Cardiovascular · 143d
Cleared Mar 14, 2014
VOLCANO IFR MODALITY
K133323 · IYO
Volcano Corporation
Radiology · 136d
Cleared Mar 14, 2014
CS 8100 3D
K133406 · OAS
Trophy
Radiology · 128d
Cleared Mar 14, 2014
DIAZYME 25-OH VITAMIN D ASSAY
K133410 · MRG
Diazyme Laboratories
Chemistry · 127d
Cleared Mar 14, 2014
TRINIA
K133608 · EBF
Bicon, LLC
Dental · 109d
Cleared Mar 14, 2014
CERASMART
K133824 · EBF
GC America, Inc.
Dental · 87d
Cleared Mar 14, 2014
STERISPINE LC CAGE
K133893 · MAX
Safe Orthopaedics
Orthopedic · 84d