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
164473–164496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1981
STERILE AIRWAY
K810069 · CAE
Medspec Corp.
Anesthesiology · 20d
Cleared Feb 02, 1981
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
K810078 · DIF
Hyland Therapeutic Div., Travenol...
Chemistry · 20d
Cleared Feb 02, 1981
CHOLESTEROL STANDARD
K810092 · JIS
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Feb 02, 1981
EMIT-ST PHENCYCLIDINE ASSAY
K810093 · LCM
Syva Co.
Toxicology · 20d
Cleared Feb 02, 1981
DENTURE RUBBER BASE MATERIAL
K810094 · EBI
Bosworth Co.
Dental · 19d
Cleared Feb 02, 1981
BCA 1000
K810105 · JJQ
Biodynamics Corp.
Chemistry · 17d
Cleared Feb 02, 1981
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K810106 · BTO
Shiley, Inc.
Anesthesiology · 17d
Cleared Feb 02, 1981
CENTRIFICHEM SYSTEM 500
K810129 · JJE
Union Carbide Corp.
Chemistry · 14d
Cleared Feb 02, 1981
URIC ACID REAGENT SYSTEM
K810136 · KNK
American Monitor Corp.
Chemistry · 12d
Cleared Feb 02, 1981
ALK-PHOS BIOPAK GEL
K810144 · CIN
Bioware Products
Chemistry · 12d
Cleared Feb 02, 1981
TEMPERATURE FUNCTION BLOCK
K810173 · FLL
Honeywell, Inc.
General Hospital · 11d
Cleared Jan 30, 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079 · KRI
3M Health Care, Sarns
Cardiovascular · 17d
Cleared Jan 29, 1981
K/K (ASMA/ANA) UNIVERSAL BIOPAK
K802299 · DHN
Bioware Products
Immunology · 132d
Cleared Jan 29, 1981
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE
K802364 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 122d
Cleared Jan 29, 1981
RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL
K803133 · LFX
Microbiological Research Corp.
Microbiology · 48d
Cleared Jan 29, 1981
TOXOPLASMA GONDII SEROLOGICAL REAGENTS
K803134 · GLZ
Microbiological Research Corp.
Microbiology · 48d
Cleared Jan 29, 1981
RUBELLA VIRUS SEROLOGICAL REAGENTS
K803175 · LFX
Microbiological Research Corp.
Microbiology · 45d
Cleared Jan 29, 1981
FIELD SUCTION DISSECTOR
K803292 · GDI
V. Mueller O.V. Baxter Healthcare Corp.
General & Plastic Surgery · 30d
Cleared Jan 29, 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Jan 29, 1981
SIEMENS-ELEMA MYOCARDIAL LEAD
K810036 · DXY
Siemens Elema AB
Cardiovascular · 20d
Cleared Jan 29, 1981
WATER RESISTANT FOOTSWITCH W/CABLE
K810101 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jan 29, 1981
INFANT ECG ELECTRODE #60-1029
K810102 · DRX
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ADULT ECG ELECTRODE #60-0724
K810103 · DRX
Aspen Laboratories, Inc.
Cardiovascular · 13d
Cleared Jan 29, 1981
ECG ARRHYTHMIA STIMULATOR
K810104 · DPS
Belmont Instrument Corp.
Cardiovascular · 13d