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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,820 results
97345–97368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1996
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K961525 · MOS
Mri Devices Corp.
Radiology · 136d
Cleared Sep 05, 1996
BETTER-VENTER
K961594 · DWF
Circulatory Technology, Inc.
Cardiovascular · 134d
Cleared Sep 05, 1996
MINI FLEX COIL
K961628 · MOS
W.L. Gore & Associates, Inc.
Radiology · 132d
Cleared Sep 05, 1996
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6...
K961969 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 108d
Cleared Sep 05, 1996
ELECT BLOOD GLUCOSE MONITORIG SYSTEM
K961985 · CGA
Selfcare, Inc.
Chemistry · 107d
Cleared Sep 05, 1996
THUMPER CARDIOPULMONARY RESUSCITATOR
K962237 · DRM
Michigan Instruments, Inc.
Cardiovascular · 86d
Cleared Sep 05, 1996
MAICO MA25 SERIES II WITH SPEECH
K962275 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 84d
Cleared Sep 05, 1996
CLAMPLESS VALVED CATHETER
K962300 · LJS
Bmw Medical, Inc.
General Hospital · 84d
Cleared Sep 05, 1996
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
K962361 · BSR
Laerdal Medical Corp.
Anesthesiology · 78d
Cleared Sep 05, 1996
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
K962484 · KTT
Synthes (Usa)
Orthopedic · 71d
Cleared Sep 05, 1996
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
K962499 · JZT
Bartels, Inc.
Immunology · 71d
Cleared Sep 05, 1996
GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
K962710 · LPL
Gelflex Laboratories
Ophthalmic · 87d
Cleared Sep 05, 1996
GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
K962711 · LPL
Gelflex Laboratories
Ophthalmic · 87d
Cleared Sep 05, 1996
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
K962910 · GZJ
Uni-Patch, Inc.
Neurology · 62d
Cleared Sep 05, 1996
RIONET HB-55AS
K963152 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 23d
Cleared Sep 05, 1996
RIONET HB-55S
K963153 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 23d
Cleared Sep 05, 1996
RIONET HB-54AS
K963154 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Sep 04, 1996
IMNI HOT PACKS
K955788 · IMD
Omni Therm, Inc.
Physical Medicine · 257d
Cleared Sep 04, 1996
MYELOTEC MYELOSCOPE
K960194 · HRX
Myelotec, Inc.
Orthopedic · 232d
Cleared Sep 04, 1996
SERAQUEST RUBELLA IGG
K961053 · LFX
Quest Intl., Inc.
Microbiology · 170d
Cleared Sep 04, 1996
OMNI COLD GEL PACKS
K961176 · IMD
Omni Therm, Inc.
Physical Medicine · 163d
Cleared Sep 04, 1996
GATED MIBI 3-D EJECTION FRACTION PROCESSING
K961597 · KPS
Trionix Research Laboratory, Inc.
Radiology · 133d
Cleared Sep 04, 1996
ACL 6000 SYSTEM (ACL 6000)
K961991 · GKP
Instrumentation Laboratory CO
Hematology · 106d
Cleared Sep 04, 1996
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
K962177 · DSP
C.R. Bard, Inc.
Cardiovascular · 90d