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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138625–138648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1987
MICRINS SURGICAL SCISSOR
K872990 · FZT
Micrins Surgical, Inc.
General & Plastic Surgery · 17d
Cleared Aug 17, 1987
MICRINS FORCEPS 2010
K872991 · GEN
Micrins Surgical, Inc.
General & Plastic Surgery · 17d
Cleared Aug 17, 1987
MIN-IDENTOFLEX
K873002 · EHJ
Centrix, Inc.
Dental · 13d
Cleared Aug 17, 1987
CONCEPT SWITCHING STICK
K873009 · KGZ
Concept, Inc.
General & Plastic Surgery · 13d
Cleared Aug 14, 1987
ANDRIES PHYSICAL ASSESSMENT COMPUTER
K870545 · DQC
Andries Tek, Inc.
Cardiovascular · 185d
Cleared Aug 14, 1987
MASCOT CW DOPPLER SYSTEM
K871212 · JOP
Imex Medical Systems, Inc.
Cardiovascular · 141d
Cleared Aug 14, 1987
FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)
K872088 · HDR
Irvine Scientific
Obstetrics & Gynecology · 74d
Cleared Aug 14, 1987
APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)
K872089 · DZE
Asahi Optical Co. C/O Rosati...
Dental · 74d
Cleared Aug 14, 1987
CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)
K872203 · HDR
Irvine Scientific
Obstetrics & Gynecology · 67d
Cleared Aug 14, 1987
CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE
K872266 · JWH
Dow Corning Wright
Orthopedic · 73d
Cleared Aug 14, 1987
TRANSPECT TRANSCRANIAL DOPPLER
K872292 · IYN
Medasonics, Inc.
Radiology · 59d
Cleared Aug 14, 1987
MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM
K872725 · GWE
Eyetronics, Inc.
Neurology · 37d
Cleared Aug 14, 1987
RATE INFUSER SYSTEM
K872850 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 25d
Cleared Aug 14, 1987
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
K872982 · NAD
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 14d
Cleared Aug 13, 1987
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265 · LBS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 135d
Cleared Aug 13, 1987
CRITERION II & IIA OXYGEN CONCENTRATORS
K871603 · CAW
Timeter Instrument Corp.
Anesthesiology · 111d
Cleared Aug 13, 1987
NOVOCHECK/CHECKPOINT/CONTROL SOLUTION
K872049 · CGA
Garid, Inc.
Chemistry · 77d
Cleared Aug 13, 1987
TDXR FLECAINIDE
K872175 · LBZ
Abbott Laboratories
Chemistry · 66d
Cleared Aug 13, 1987
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191 · CDP
Immunotech Corp.
Chemistry · 66d
Cleared Aug 13, 1987
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
K872192 · KLI
Immunotech Corp.
Chemistry · 66d
Cleared Aug 13, 1987
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
K872197 · CIG
Sigma Diagnostics, Inc.
Chemistry · 66d
Cleared Aug 13, 1987
HR (TM) COLLECTION SYSTEM
K872580 · FMI
Icu Medical, Inc.
General Hospital · 44d
Cleared Aug 13, 1987
EASY ST ANALYZER SYSTEM
K872813 · JJE
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Aug 13, 1987
BIOTROL AST/TGO MONOREACTIF
K872829 · CIT
Biotrol, USA, Inc.
Chemistry · 27d