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
147601–147624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1985
APO B RIA KIT
K851389 · MSJ
Iso-Tex Diagnostics
Immunology · 92d
Cleared Jul 10, 1985
ANA/LITE-RL TEST SYSTEM
K852230 · LJM
Immuno-Products Industries
Immunology · 49d
Cleared Jul 10, 1985
ANA/LITE-HEP-2 TEST SYSTEM
K852231 · LJM
Immuno-Products Industries
Immunology · 49d
Cleared Jul 10, 1985
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K852247 · DDB
Behring Diagnostics, Inc.
Immunology · 48d
Cleared Jul 10, 1985
QUANTICLONE IGE RADIOIMMUNASSAY
K852268 · DGC
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Jul 09, 1985
MODEL 1000
K844727 · IPF
Verite
Physical Medicine · 217d
Cleared Jul 09, 1985
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
K850020 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 186d
Cleared Jul 09, 1985
CHOLESTEROL TEST SYSTEM
K850390 · CHH
Hans J. Brouwers & Assoc.
Hematology · 158d
Cleared Jul 09, 1985
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · LGD
Abbott Laboratories
Microbiology · 147d
Cleared Jul 09, 1985
CHEM PRO 1000 CHEMISTRY ANALYSIS
K851100 · CEM
Sen Tech Medical Corp.
Chemistry · 112d
Cleared Jul 09, 1985
BLHI LUTEINIZING HORMONE
K851332 · CEP
Euro-Diagnostics BV
Chemistry · 96d
Cleared Jul 09, 1985
AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRS
K851548 · INM
Daun International, Inc.
Physical Medicine · 84d
Cleared Jul 09, 1985
MERIVAARA GERIATRIC CHAIR
K851550 · INM
Daun International, Inc.
Physical Medicine · 84d
Cleared Jul 09, 1985
MERIUAARA & ERACARE WHEELCHAIRS
K851553 · IOR
Daun International, Inc.
Physical Medicine · 84d
Cleared Jul 09, 1985
TMX-70 TREADMILL
K851629 · IOL
Eaton Medical Group
Physical Medicine · 82d
Cleared Jul 09, 1985
TMX-80 TREADMILL
K851630 · IOL
Eaton Medical Group
Physical Medicine · 82d
Cleared Jul 09, 1985
NYHUS/NELSON TUBE
K851672 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1985
27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF
K851786 · LGG
Artiberia
Orthopedic · 75d
Cleared Jul 09, 1985
WHEELCHAIR CUSHIONS
K851814 · KIC
Dignicare
Physical Medicine · 74d
Cleared Jul 09, 1985
CURING LIGHT
K851915 · EBZ
Technology, Inc.
Dental · 69d
Cleared Jul 09, 1985
LASER PLATELETCAL/MULTIPLE
K852016 · KRY
R&D Systems, Inc.
Hematology · 61d
Cleared Jul 09, 1985
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Jul 09, 1985
LEE-BEAD TSH(EIA)
K852224 · JLW
Lecco Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 09, 1985
DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)
K852280 · KKX
Outpatient Products Co.
General Hospital · 41d