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
162721–162744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1981
AMERLEX TSH RIA KIT
K812136 · JLW
Amersham Corp.
Chemistry · 16d
Cleared Aug 13, 1981
LIC 180 MEDICAL LAMPS
K812142 · KZF
Lada Intl., Inc.
General Hospital · 16d
Cleared Aug 13, 1981
LIFE-TECH #'S 1106/1156 UROLABS
K812178 · FAP
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 10d
Cleared Aug 12, 1981
USCI DOPPLER CATHETER SYSTEM
K810414 · JOP
C.R. Bard, Inc.
Cardiovascular · 175d
Cleared Aug 12, 1981
DOPPLER ULTRASOUND BLOOD FLOWMETER
K811246 · DPW
Irex Corp.
Cardiovascular · 99d
Cleared Aug 12, 1981
ANTI-SKIN ANTIBODY TEST SYSTEM
K811261 · DBL
Zeus Scientific, Inc.
Microbiology · 98d
Cleared Aug 12, 1981
MOORE HIP PROSTHESIS, PMMA COATED
K811416 · KWL
Zimmer, Inc.
Orthopedic · 85d
Cleared Aug 12, 1981
SP-100-B SMALL PARTS SCANNER SYSTEM
K811595 · DXK
Highstoy
Radiology · 65d
Cleared Aug 12, 1981
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
K811613 · DDG
Kent Laboratories, Inc.
Immunology · 65d
Cleared Aug 12, 1981
BLUING REAGENT
K811800 · PPM
Richard-Allan Medical Ind., Inc.
Hematology · 49d
Cleared Aug 12, 1981
SICKLE CELL REAGENT SET
K811828 · GHM
Anco Medical Reagents & Assoc.
Chemistry · 44d
Cleared Aug 12, 1981
TEFLON PLEDGET SUTURE BUTTRESS
K811872 · DXZ
Ethicon, Inc.
Cardiovascular · 42d
Cleared Aug 12, 1981
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978 · GKL
Technicon Instruments Corp.
Hematology · 30d
Cleared Aug 12, 1981
SIMVAC
K811991 · CBO
The Lynn Terrell Co.
Anesthesiology · 30d
Cleared Aug 12, 1981
LPC II
K812031 · GKL
Labtronix Corp.
Hematology · 23d
Cleared Aug 12, 1981
ENDAB DIGOXIN KIT
K812054 · KXT
Immunotech Corp.
Toxicology · 22d
Cleared Aug 12, 1981
SPECTRO FEIRITIN
K812056 · DBF
Ramco Laboratories, Inc.
Microbiology · 22d
Cleared Aug 12, 1981
INSPIRATORY FORCE PRESSURE ADAPTOR
K812067 · BZA
Airlife, Inc.
Anesthesiology · 22d
Cleared Aug 12, 1981
NICHOLE'S 99
K812075 · CAH
Healthcare Ind.
General Hospital · 21d
Cleared Aug 12, 1981
ANTI-GM & ANTI-KM TYPING SERUMS
K812076 · DGH
Biotest-Serum-Institut
Immunology · 21d
Cleared Aug 12, 1981
WAKO NEFA C TEST
K812081 · JLG
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared Aug 12, 1981
FAST CHOLES-CINET
K812091 · CHH
Sclavo, Inc.
Chemistry · 20d
Cleared Aug 12, 1981
SERALYZER
K812100 · CHH
Miles Laboratories, Inc.
Chemistry · 19d
Cleared Aug 10, 1981
ATL'S MARK 100/300 ULTRASOUND SYSTEMS
K811572 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 67d