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
111217–111240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1993
ORION YAG LASER SYSTEM OPHTHALMOLOGY
K910826 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 998d
Cleared Nov 16, 1993
ORION
K911288 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 992d
Cleared Nov 16, 1993
MENLO CARE AQUASTENT SET
K923394 · FAD
Menlo Care, Inc.
Gastroenterology & Urology · 494d
Cleared Nov 16, 1993
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA
K925093 · JJF
Beckman Instruments, Inc.
Chemistry · 405d
Cleared Nov 16, 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · JDR
Zimmer, Inc.
Orthopedic · 329d
Cleared Nov 16, 1993
PLUMEMASTER SMOKE EVACUATION SYSTEM
K930434 · FYD
Sorenson Laboratories, Inc.
General Hospital · 294d
Cleared Nov 16, 1993
MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS
K930831 · JWH
Zimmer, Inc.
Orthopedic · 272d
Cleared Nov 16, 1993
UROPAPER
K931897 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
K932049 · CIT
Stanbio Laboratory
Chemistry · 203d
Cleared Nov 16, 1993
MIRACLE GLOVE UNDER THE GLOVE GLOVING CREAM
K932061 · KGO
Advanced Chemical Technology, Inc.
General Hospital · 202d
Cleared Nov 16, 1993
UROPAPER EIKEN GK
K932363 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
UROPAPER EIKEN GP
K932364 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
UROPAPER EIKEN 8
K932367 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
UROPAPER EIKEN 7
K932369 · JIL
Tanabe U.S.A., Inc.
Chemistry · 211d
Cleared Nov 16, 1993
DIGITAL BABY SCALE MODEL BLB-12
K932572 · FRW
Tanita Corp. of America
General Hospital · 173d
Cleared Nov 16, 1993
FIBER OPTIC LIGHT CABLE
K932629 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 168d
Cleared Nov 16, 1993
XENON LIGHT SOURCE ILLUMINATOR
K932631 · GCJ
Stephen Chakoff, Inc.
General & Plastic Surgery · 168d
Cleared Nov 16, 1993
PHARMAFEED
K932649 · KPE
Plasco, Inc.
General Hospital · 167d
Cleared Nov 16, 1993
STAINLESS STEEL ARCHES REPACKER RELABETER
K933377 · DZC
Highland Metals
Dental · 130d
Cleared Nov 16, 1993
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
K933425 · DKC
Sigma Diagnostics, Inc.
Chemistry · 126d
Cleared Nov 16, 1993
PASCO MIC AND MIC/ID PANELS
K933849 · JWY
Pasco Laboratories, Inc.
Microbiology · 103d
Cleared Nov 16, 1993
ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K933885 · JWY
Alamar Biosciences, Inc.
Microbiology · 98d
Cleared Nov 16, 1993
VISION PROPHY PASTE WITHOUT FLUORIDE
K933893 · EJR
Block Drug Company, Inc.
Dental · 98d
Cleared Nov 16, 1993
FT4 RADIOIMMUNOASSAY
K934012 · CEC
Immunotech S.A.
Chemistry · 90d