FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90097–90120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 03, 1998
SPECTRUM DESIGNS PROFILE MALAR IMPLANT
K980139 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
K980140 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
K980141 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
QUICKPAC II ONE STEP BARBITURATE TEST
K980349 · DIS
Syntron Bioresearch, Inc.
Toxicology · 34d
Cleared Mar 03, 1998
PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL...
K980381 · LHI
Carmel Pharma Ab.
General Hospital · 29d
Cleared Mar 03, 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER...
K980414 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Mar 03, 1998
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
K980528 · MMI
Chiron Diagnostics Corp.
Chemistry · 20d
Cleared Mar 02, 1998
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
K971028 · HIS
Worlds-Best Gummivarefabrik A/S
Obstetrics & Gynecology · 347d
Cleared Mar 02, 1998
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
K971759 · BTR
Green Field Medical Sourcing, Inc.
Anesthesiology · 294d