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
89209–89232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1998
REFRACTEC MCS-100
K980522 · HQR
Refractec, Inc.
Ophthalmic · 162d
Cleared Jul 22, 1998
VCA IGM ELISA TEST SYSTEM
K980596 · LSE
Clark Laboratories, Inc.
Microbiology · 155d
Cleared Jul 22, 1998
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
K980635 · GKZ
Dako Corp.
Hematology · 153d
Cleared Jul 22, 1998
VCA IGG ELISA TEST SYSTEM
K980912 · LSE
Clark Laboratories, Inc.
Microbiology · 134d
Cleared Jul 22, 1998
SUPERGLOVES POWDERED NITRILE
K980966 · LZA
Supermax Sdn Bhd
General Hospital · 128d
Cleared Jul 22, 1998
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL...
K981083 · DTB
Biotronik, Inc.
Cardiovascular · 120d
Cleared Jul 22, 1998
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY...
K981444 · JHI
Princeton BioMeditech Corp.
Chemistry · 91d
Cleared Jul 22, 1998
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
K981493 · CHH
Polymer Technology Systems, Inc.
Chemistry · 86d
Cleared Jul 22, 1998
TIBC
K981654 · JMO
Abbott Laboratories
Chemistry · 72d
Cleared Jul 22, 1998
WIELISA ANCA SCREENING KIT TEST SYSTEM
K981748 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 22, 1998
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
K981750 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 22, 1998
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
K981760 · HEB
Playtime Products, Inc.
Obstetrics & Gynecology · 64d
Cleared Jul 22, 1998
CREA
K981799 · CGX
Abbott Laboratories
Chemistry · 62d
Cleared Jul 22, 1998
ALBP
K981814 · CJW
Abbott Laboratories
Chemistry · 61d
Cleared Jul 22, 1998
AMM
K981920 · JIF
Abbott Laboratories
Chemistry · 51d
Cleared Jul 22, 1998
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K981926 · DLJ
Emd Chemicals, Inc.
Toxicology · 50d
Cleared Jul 22, 1998
DBIL
K981943 · CIG
Abbott Laboratories
Chemistry · 49d
Cleared Jul 22, 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978 · MRR
Pointe Scientific, Inc.,
Chemistry · 47d
Cleared Jul 22, 1998
TRUBYTE DENTURE BOND DENTURE BONDING AGENT
K982007 · KLE
Dentsply Intl.
Dental · 44d
Cleared Jul 22, 1998
VERABOND 2
K982094 · EJH
Aalba Dent, Inc.
Dental · 37d
Cleared Jul 22, 1998
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277 · CHL
Nova Biomedical Corp.
Chemistry · 23d
Cleared Jul 22, 1998
CHEM-CHEX STAT (NEW)
K982290 · JJY
Streck Laboratories, Inc.
Chemistry · 23d
Cleared Jul 21, 1998
LAPARO-TENSER
K970712 · HET
L & T S.N.C. DI E. Lucini & C.
Obstetrics & Gynecology · 510d
Cleared Jul 21, 1998
MODEL 02 OXYGEN ANALYZER
K971084 · CCL
Oxigraf, Inc.
Anesthesiology · 483d