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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90601–90624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1998
BIOSENSOR HOLTER MONITOR SYSTEM
K974546 · DQK
Biosensor Corp.
Cardiovascular · 90d
Cleared Mar 04, 1998
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
K974558 · JDI
Biomet, Inc.
Orthopedic · 89d
Cleared Mar 04, 1998
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA...
K974614 · LNH
Elscint, Inc.
Radiology · 83d
Cleared Mar 04, 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K974624 · LPN
Alcon Laboratories
Ophthalmic · 83d
Cleared Mar 04, 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K974625 · LPN
Alcon Laboratories
Ophthalmic · 83d
Cleared Mar 04, 1998
MATRIX MT-MX3
K974700 · IYE
Medtec, Inc.
Radiology · 78d
Cleared Mar 04, 1998
DYNA VUE 3-D IMAGING PRODUCT
K974755 · LLZ
Imd Systems, Inc.
Radiology · 75d
Cleared Mar 04, 1998
CYBERSONIC
K980075 · LCN
American Dentronics, Inc.
Dental · 55d
Cleared Mar 04, 1998
J-TIP NEEDLESS INJECTOR
K980082 · KZE
National Medical Products, Inc.
General Hospital · 54d
Cleared Mar 04, 1998
FLEXIGEL-G HYDROGEL WOUND DRESSING
K980097 · MGQ
Innovative Technologies , Ltd.
General & Plastic Surgery · 51d
Cleared Mar 04, 1998
IMPLANT SITE DILATORS
K980374 · DZE
BioHorizons Implant Systems, Inc.
Dental · 33d
Cleared Mar 04, 1998
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
K980461 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 27d
Cleared Mar 04, 1998
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL...
K980514 · JJY
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Mar 03, 1998
PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE
K962903 · FLE
Prestige Medical Corp.
General Hospital · 586d
Cleared Mar 03, 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · GTZ
Abbott Laboratories
Microbiology · 312d
Cleared Mar 03, 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · LYR
Boehringer Mannheim Corp.
Microbiology · 167d
Cleared Mar 03, 1998
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
K974084 · FSY
Getinge/Castle, Inc.
General & Plastic Surgery · 125d
Cleared Mar 03, 1998
MENISCAL REPAIR DEVICE
K974538 · HWC
Linvatec Corp.
Orthopedic · 90d
Cleared Mar 03, 1998
SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)
K974555 · JEY
Synthes (Usa)
Dental · 89d
Cleared Mar 03, 1998
IS-DSDNA TEST SYSTEM
K974694 · LRM
Diamedix Corp.
Immunology · 77d
Cleared Mar 03, 1998
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
K974721 · CGI
Bayer Corp.
Chemistry · 75d
Cleared Mar 03, 1998
IMTEC/BIOBARRIER MEMBRANE
K974752 · NPK
Imtec Corp.
Dental · 74d
Cleared Mar 03, 1998
PREPQUICK
K974786 · KLE
Ultradent Products, Inc.
Dental · 71d
Cleared Mar 03, 1998
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
K980031 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 57d