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
89065–89088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1998
AIC - CHEK (HBAIC-I)
K973365 · LCP
Express-Med, Inc.
Hematology · 280d
Cleared Jun 15, 1998
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · LOS
Hewlett-Packard Co.
Cardiovascular · 229d
Cleared Jun 15, 1998
ETEST BENZYLPENICILLIN
K980335 · JWY
Ab Biodisk
Microbiology · 138d
Cleared Jun 15, 1998
SERAQUEST ANTI-SM
K980540 · LKP
Quest Intl., Inc.
Immunology · 123d
Cleared Jun 15, 1998
SERAQUEST ANTI-SSB
K980639 · LLL
Quest Intl., Inc.
Immunology · 116d
Cleared Jun 15, 1998
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
K980980 · FFX
Konigsberg Instruments, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 15, 1998
KSEA CALCUSPLIT
K981233 · FFK
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 73d
Cleared Jun 15, 1998
CCA-200
K981439 · EWO
Benson Medical Instruments Co.
Ear, Nose, Throat · 55d
Cleared Jun 15, 1998
COLOR-SLIDE RF
K981496 · DHR
Seradyn, Inc.
Immunology · 49d
Cleared Jun 15, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
K981632 · CIG
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 38d
Cleared Jun 15, 1998
I-STAT COAGULATION CONTROL SET
K981752 · GGN
Biopool Intl., Inc.
Hematology · 28d
Cleared Jun 12, 1998
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
K973096 · KPI
Neotonus, Inc.
Gastroenterology & Urology · 297d
Cleared Jun 12, 1998
RESPIRTECHPRO
K973975 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 235d
Cleared Jun 12, 1998
COSGROVE CLAMP
K974769 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 172d
Cleared Jun 12, 1998
56 SERIES AEROSOL GENERATOR
K980074 · CAF
Project Marketing
Anesthesiology · 155d
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
K980289 · KGI
Norland Corp.
Radiology · 137d
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
K980569 · KGI
Norland Corp.
Radiology · 119d
Cleared Jun 12, 1998
RIGID CULDOSCOPE AND ACCESSORIES
K980972 · HEW
Circon Corp.
Obstetrics & Gynecology · 88d
Cleared Jun 12, 1998
FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE
K980979 · CCK
Fukuda Denshi USA, Inc.
Anesthesiology · 87d
Cleared Jun 12, 1998
VARIAN XIMATRON SCAN VISION CT
K981056 · KPR
Varian Medical Systems, Inc.
Radiology · 81d
Cleared Jun 12, 1998
PHOS
K981118 · CEO
Abbott Laboratories
Chemistry · 77d
Cleared Jun 12, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K981638 · DCK
Beckman Coulter, Inc.
Immunology · 35d
Cleared Jun 12, 1998
ALBG
K981758 · CIX
Abbott Laboratories
Chemistry · 24d
Cleared Jun 12, 1998
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · DJG
Princeton BioMeditech Corp.
Toxicology · 24d