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
160201–160224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1982
THORACIC DRAINAGE SYSTEM
K821023 · GCX
Howmedica Corp.
General Hospital · 38d
Cleared May 21, 1982
STERILE PATIENT EXAM. GLOVES
K821043 · FMC
Phoenix Glove Co.
General Hospital · 37d
Cleared May 21, 1982
DISPOSABLE THUMB FORCEPS
K821143 · GEN
Medcare Products
General & Plastic Surgery · 30d
Cleared May 21, 1982
BITE STICK
K821177 · FMA
Abco Dealers, Inc.
General Hospital · 24d
Cleared May 21, 1982
TRACELON
K821180 · BTR
Terumo Medical Corp.
Anesthesiology · 24d
Cleared May 21, 1982
URIC ACID REAGENT SET(ENZYMATIC
K821214 · KNK
Omega Medical Electronics
Chemistry · 24d
Cleared May 21, 1982
ALBUMIN REAGENT
K821225 · CIX
Hi Chem, Inc.
Chemistry · 24d
Cleared May 21, 1982
RIAGEN B-HCG RIA
K821234 · JHI
Biogenex Laboratories
Chemistry · 23d
Cleared May 21, 1982
NEUROMATIC 2000
K821237 · IKN
Disa Electronics
Neurology · 23d
Cleared May 21, 1982
LIQUID-STAT LIQUID ENZYME REAGENT
K821240 · CGS
Beckman Instruments, Inc.
Chemistry · 22d
Cleared May 21, 1982
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242 · JJY
Beckman Instruments, Inc.
Chemistry · 22d
Cleared May 21, 1982
ENDOTRACHEAL TUBE
K821243 · BTR
Life-Line Products, Inc.
Anesthesiology · 22d
Cleared May 21, 1982
ACCUDEX REAGENT STRIPS
K821247 · CGA
Miles Laboratories, Inc.
Chemistry · 22d
Cleared May 21, 1982
ESPREE' GUEDEL ESPREE BERMAN AIRWAY
K821308 · CAE
Esp Plastics, Inc.
Anesthesiology · 17d
Cleared May 21, 1982
ESPREE', BREATHING BAG
K821309 · BTC
Esp Plastics, Inc.
Anesthesiology · 17d
Cleared May 21, 1982
ESPREE' BREATHING CIRCUIT (W/ACCESS
K821311 · CAI
Esp Plastics, Inc.
Anesthesiology · 17d
Cleared May 21, 1982
SERO/TEX RF TEST
K821319 · DHR
Texas Immunology, Inc.
Immunology · 17d
Cleared May 21, 1982
TRANSENDOSCOPIC INJECTION CATHETER TEI
K821336 · KNY
Sounson Research Co., Inc.
Gastroenterology & Urology · 16d
Cleared May 21, 1982
METAL BACKED ACETABULAR COMPONENT
K821342 · JOL
Intermedics Orthopedics
General Hospital · 16d
Cleared May 21, 1982
TITANIUM AUFRANC-TURNER ATS HIP SYS
K821369 · JDI
Howmedica Corp.
Orthopedic · 11d
Cleared May 21, 1982
LIGHT WEIGHT ALUMINUM WALKER
K821404 · ITJ
Manuco Manufacturing Co., Inc.
Physical Medicine · 10d
Cleared May 20, 1982
J.E.T. DIALYSIS SYSTEM
K820575 · FKJ
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 78d
Cleared May 19, 1982
DIAGNOSTIC X-RAY HV GENERATOR
K827378
Technicare Corp.
Radiology · 29d
Cleared May 19, 1982
X-RAY CASSETTE
K827379
Synchroplan Corp.
Radiology · 30d