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
163633–163656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1981
SERO-STAT STAPHYLOCOCCUS TEST
K811098 · JWX
Scott Laboratories, Inc.
Microbiology · 13d
Cleared May 05, 1981
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
K811102 · CBK
Siemens Elema AB
Anesthesiology · 14d
Cleared May 05, 1981
SURGICAL STAPLE REMOVER
K811120 · KDC
Acme United Corp.
General & Plastic Surgery · 11d
Cleared May 05, 1981
BRUCELLA AGAR
K811128 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
LAURYL SULFATE BROTH
K811129 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
LACTOSE BROTH
K811130 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
HEKTOEN ENTERIC AGAR
K811131 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
EUGON BROTH
K811132 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
EOSIN-METHYLENE BLUE AGAR
K811133 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
ACU-DESOXYCHOLATE AGAR
K811134 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
COLUMBIA BLOOD AGAR BASE
K811135 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
MUELLER HINTON BROTH
K811136 · JTZ
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
COLUMBIA CNA AGAR
K811137 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
NUTRIENT AGAR
K811138 · JSQ
Acumedia Manufacturers, Inc.
Microbiology · 11d
Cleared May 05, 1981
MODEL RXO2 OXYGEN RICH AIR SUPPLY
K811155 · CAW
Greene & Kellogg, Inc.
Anesthesiology · 7d
Cleared May 01, 1981
PORTADIAL CARRY-ON KIDNEY MACHINE
K802297 · FKQ
Alan P. Kendal, Ph.D.
Gastroenterology & Urology · 224d
Cleared May 01, 1981
DOP 84
K810155
Medlog GmbH Marketing Services
Radiology · 100d
Cleared May 01, 1981
BREATH METER
K810437 · BZG
Fred Sammons, Inc.
Anesthesiology · 71d
Cleared May 01, 1981
TRANSMITTER & RECEIVERS, TELEPHONE, ELEC
K810608 · DXH
Heart Check Systems, Inc.
Cardiovascular · 56d
Cleared May 01, 1981
VARIODRAIN
K810636 · GCY
Colmed, Ltd.
General & Plastic Surgery · 52d
Cleared May 01, 1981
THINLITH III UNIPOLAR CARDIAC PULSE GEN.
K810752 · DXY
Intermedics, Inc.
Cardiovascular · 42d
Cleared May 01, 1981
MODEL 230-05 CYBERLITH I BIPOL. PULSE G.
K810800 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared May 01, 1981
PRITCHARD SURFACE REPLACEMENT ELBOW
K810847 · JDB
Depuy, Inc.
Orthopedic · 35d
Cleared May 01, 1981
EEG TELEPHONE RECEIVER MODEL #AFR-J
K810872 · DXH
Telediagnostic Systems, Inc.
Cardiovascular · 31d