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
97345–97368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1996
SURE CHECK PREGNANCY TEST
K961965 · LCX
Chembio Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jun 24, 1996
CIBA CORNING 348 SYSTEM
K962021 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 32d
Cleared Jun 24, 1996
MAGNETO EYEWEAR
K962169 · HQY
Nike, Inc.
Ophthalmic · 19d
Cleared Jun 21, 1996
IMMULITE HERPES I AND II IGG
K950670 · LGC
Diagnostic Products Corp.
Microbiology · 494d
Cleared Jun 21, 1996
AMYLASE (ETHYLIDENE PNGPG7) KIT
K953211 · CIJ
Randox Laboratories, Ltd.
Chemistry · 347d
Cleared Jun 21, 1996
KNOW-RECIRC
K953551 · MQS
H&H Control Systems
Gastroenterology & Urology · 329d
Cleared Jun 21, 1996
DISPOSABLE ECG ELECTRODE
K953649 · DRX
Kendall-Ltp
Cardiovascular · 322d
Cleared Jun 21, 1996
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
K954514 · KQO
Sciteck Diagnostics, Inc.
Chemistry · 267d
Cleared Jun 21, 1996
LUMISCOPE MODEL 2018 THERMOMETER
K954792 · FLL
Lumiscope Co., Inc.
General Hospital · 247d
Cleared Jun 21, 1996
CALIBRATION SERUM LEVEL 1 & 2
K955489 · JIX
Randox Laboratories, Ltd.
Chemistry · 207d
Cleared Jun 21, 1996
K-Y PERSONAL LUBRICANT
K955648 · HIS
Ortho Pharmaceutical Corp.
Obstetrics & Gynecology · 192d
Cleared Jun 21, 1996
FENNING FEMORAL COMPONENT
K960303 · LPH
Biomet, Inc.
Orthopedic · 151d
Cleared Jun 21, 1996
HANDSAFE
K960386 · LYY
Handsafe Products Sdn. Bhd.
General Hospital · 147d
Cleared Jun 21, 1996
WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)
K960978 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 102d
Cleared Jun 21, 1996
HUMPHREY OCT SCANNER
K961171 · HLI
Carl Zeiss, Inc.
Radiology · 88d
Cleared Jun 21, 1996
ECG MONITOR MODEL DS-3130/3140
K961174 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 88d
Cleared Jun 21, 1996
NMI ANTEGRAD CARDIOPLEGIA CANNULA
K961180 · DWF
Naltiac Medical, Inc.
Cardiovascular · 87d
Cleared Jun 21, 1996
NMI VEIN GRAFT PERFUSION SET
K961181 · DTL
Naltiac Medical, Inc.
Cardiovascular · 87d
Cleared Jun 21, 1996
SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES
K961197 · GEI
Conmedcorp
General & Plastic Surgery · 86d
Cleared Jun 21, 1996
PERCUTANEOUS INTRODUCER SYSTEM
K961219 · GEH
Boston Scientific Corp
General & Plastic Surgery · 85d
Cleared Jun 21, 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225 · FPA
Baxter Healthcare Corp
General Hospital · 84d
Cleared Jun 21, 1996
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282 · CFR
Diagnostic Chemicals , Ltd.
Chemistry · 79d
Cleared Jun 21, 1996
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
K961326 · CEM
Medica Corp.
Chemistry · 74d
Cleared Jun 21, 1996
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
K961337 · CGA
Medisense, Inc.
Chemistry · 74d