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
167329–167352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1980
ECA GEL
K792488 · GYB
Vanaray Laboratories, Inc.
Neurology · 64d
Cleared Feb 05, 1980
UCA CREAM
K792489 · IYO
Vanaray Laboratories, Inc.
Radiology · 64d
Cleared Feb 05, 1980
ECA CREAM
K792491 · GYB
Vanaray Laboratories, Inc.
Neurology · 64d
Cleared Feb 05, 1980
UCA GEL
K792492 · IYO
Vanaray Laboratories, Inc.
Radiology · 64d
Cleared Feb 05, 1980
PULSE GENERATOR, MODEL NO. LIT 222
K792526 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
SORIN PULSE GENERATOR MODEL # LIT 214 H
K792565 · DXY
Bentley Laboratories, Inc.
Cardiovascular · 60d
Cleared Feb 05, 1980
RMC KNEE METAL SHOE TIBIAL COMPONENTS
K792619 · HRY
Richard'S Medical Equip., Inc.
Orthopedic · 48d
Cleared Feb 05, 1980
PERMADYNE POLYETHER RUBBER IMPRESSION
K800031 · ELW
Espe Dental Products
Dental · 29d
Cleared Feb 05, 1980
PLATELET RETENTION (ADHESION) COLUMNS
K800037 · JBZ
Hemometrix
Hematology · 29d
Cleared Feb 05, 1980
KODAK EKTACHEM ELECTROLYTE ANALYZER
K800054 · CEM
Eastman Kodak Company
Chemistry · 27d
Cleared Feb 05, 1980
ASI REAGENT
K800065 · CIT
Gilford Diagnostics
Chemistry · 25d
Cleared Feb 05, 1980
ELECTRICAL MUSCLE STIMULATOR (EMS)
K800068 · IPF
Staodynamics, Inc.
Physical Medicine · 25d
Cleared Feb 05, 1980
GLUCOSE OXIDASE REAGENT KIT
K800070 · CGA
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 05, 1980
BUN REAGENT KIT
K800071 · CDS
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 05, 1980
TRANSCUTANEOUS OXYGEN MONITOR
K800073
Biochem International, Inc.
Cardiovascular · 22d
Cleared Feb 05, 1980
BRIOX MODEL-AEROMIST
K800078
Briox Technologies, Inc.
Cardiovascular · 22d
Cleared Feb 05, 1980
STORZ SUPER SORB MICRO EYE SPONGE
K800082 · EFQ
Storz Instrument Co.
General & Plastic Surgery · 22d
Cleared Feb 05, 1980
CHICK SURGICAL TABLE
K800118 · FWY
Warner-Lambert Co.
General & Plastic Surgery · 18d
Cleared Feb 05, 1980
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119 · DEW
Calbiochem-Behring Corp.
Immunology · 18d
Cleared Feb 05, 1980
TECHNICON C/90 SYSTEM
K800121 · GKZ
Technicon Instruments Corp.
Hematology · 18d
Cleared Feb 05, 1980
ULTRASOFT GOWN
K800124 · FYA
Mars Mfg Co.
General Hospital · 18d
Cleared Feb 05, 1980
PLATELET AGGREGATION REAGENTS
K800146 · JOZ
Pacific Hemostasis
Hematology · 14d
Cleared Feb 05, 1980
EMIT TOBRAMYCIN ASSAY
K800150 · LCD
Syva Co.
Toxicology · 14d
Cleared Feb 05, 1980
EMIT TOBRAMYCIN CONTROL
K800151 · DPW
Syva Co.
Toxicology · 14d