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
166153–166176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1980
FIBER OPTIC HOSE
K801592 · EAY
Lares Manufacturing Co., Inc.
Dental · 10d
Cleared Jul 21, 1980
ASPIRATOR
K801620 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 6d
Cleared Jul 18, 1980
ORGANON ARTERIAL BLOOD SAMPLER
K801435 · CBT
Akzona, Inc.
Anesthesiology · 29d
Cleared Jul 14, 1980
LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
K800624 · KPO
Travenol Laboratories, S.A.
Gastroenterology & Urology · 117d
Cleared Jul 14, 1980
AMBULATORY INFUSION PUMP, CODE 2M9807
K800627 · FRN
Travenol Laboratories, S.A.
General Hospital · 117d
Cleared Jul 14, 1980
ANTIBODY TO VARICELLA-ZOSTER VIRUS
K800787 · GGW
Electro-Nucleonics Laboratories, Inc.
Microbiology · 97d
Cleared Jul 14, 1980
DOUCHE UNIT-1500 ML DISP. CONTAINER
K800957 · HED
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 82d
Cleared Jul 14, 1980
MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.
K801138 · DRS
Gics Pharmaceuticals
Cardiovascular · 63d
Cleared Jul 14, 1980
COBE HEMOFLO BLOOD TUBING SETS
K801211 · FJK
Cobe Laboratories, Inc.
Gastroenterology & Urology · 55d
Cleared Jul 14, 1980
STERILE, DISP DOME, INDIVID. PKG.
K801239 · DRS
Pacific Domes, Inc.
Cardiovascular · 48d
Cleared Jul 14, 1980
WHITE BLOOD CELL COUNT CONTROL LEVELS
K801265 · JPK
Bioscientific
Hematology · 47d
Cleared Jul 14, 1980
RED BLOOD CELL COUNT & HEMATOCRIT CNTL
K801267 · JPK
Bioscientific
Hematology · 47d
Cleared Jul 14, 1980
HEMOGLOBIN CONTROL LEVELS
K801268 · KHG
Bioscientific
Hematology · 47d
Cleared Jul 14, 1980
COBAS CK-NAC REAGENT
K801299 · CGS
Roche Analytical Instruments, Inc.
Chemistry · 42d
Cleared Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318 · JHX
Helena Laboratories
Chemistry · 36d
Cleared Jul 14, 1980
ACUVAC(TM) SUCTION RESERVOIR 400CC AND
K801350 · GCY
Innovative Surgical Products, Inc.
General & Plastic Surgery · 35d
Cleared Jul 14, 1980
CARDIOTOMY RESERVOIR WITH FILTER
K801360 · DTP
Travenol Laboratories, S.A.
Cardiovascular · 35d
Cleared Jul 14, 1980
BECKMAN MODEL 42 SPECTROPHOTOMETER
K801373 · JJQ
Beckman Instruments, Inc.
Chemistry · 34d
Cleared Jul 14, 1980
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K801375 · DTP
Shiley, Inc.
Cardiovascular · 33d
Cleared Jul 14, 1980
HIPP BUFFER(NON-BARBITAL), P/N
K801378 · JJN
Gelman Sciences, Inc.
Chemistry · 33d
Cleared Jul 14, 1980
PRE-DENT SYSTEM OR PRE-DENT II
K801386 · KSS
Pre-Dent System
Hematology · 31d
Cleared Jul 14, 1980
DISC 120 TRANSPORTER
K801391 · JZW
Travenol Laboratories, S.A.
Immunology · 31d
Cleared Jul 14, 1980
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
K801409 · JHI
Travenol Laboratories, S.A.
Chemistry · 28d
Cleared Jul 14, 1980
RH CONTROL
K801425 · KSF
North American Biologicals, Inc.
Hematology · 27d