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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118921–118944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1991
WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY
K914277 · FGE
Schneider U.S. Stent Div.
Gastroenterology & Urology · 66d
Cleared Nov 29, 1991
PNEUMO-SEAL(TM)
K914470 · GCJ
Edward Weck, Inc.
General & Plastic Surgery · 53d
Cleared Nov 29, 1991
MICRO EIA FOR MARIJUANA METABOLITES
K914490 · LDJ
Microdiagnostics, Inc.
Toxicology · 52d
Cleared Nov 29, 1991
ANGLED BLADE PLATE
K914546 · KTW
Synthes (Usa)
Orthopedic · 49d
Cleared Nov 29, 1991
STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL
K914560 · CHL
Ppg Industries, Inc.
Chemistry · 45d
Cleared Nov 29, 1991
SWEDE CROSS MANUAL WHEELCHAIR
K914610 · IOR
Etac Us, Inc.
Physical Medicine · 43d
Cleared Nov 29, 1991
SYVA EMIT D.A.U. COCAINE METABOLITE
K914973 · DIO
Syva Co.
Toxicology · 23d
Cleared Nov 29, 1991
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
K915003 · DKB
Syva Co.
Toxicology · 22d
Cleared Nov 27, 1991
ENDOSSEOUS IMPLANTS
K904236 · DZE
Attachments Intl., Inc.
Dental · 436d
Cleared Nov 27, 1991
FVP-1000 FAMILY AND FVP-1000D FAMILY
K905694 · JAA
Fischer Imaging Corp.
Radiology · 343d
Cleared Nov 27, 1991
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · CAC
Shiley, Inc.
Anesthesiology · 265d
Cleared Nov 27, 1991
ACE CORTICAL BONE SCREW
K912598 · HWC
Ace Medical Co.
Orthopedic · 170d
Cleared Nov 27, 1991
MEDICAL TAPE
K912623 · KGX
Renfrew Tape, Ltd.
General & Plastic Surgery · 167d
Cleared Nov 27, 1991
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
K912641 · LZO
Biopro, Inc.
Orthopedic · 166d
Cleared Nov 27, 1991
VESSEL DILATOR
K913027 · DRE
Deseret Medical, Inc.
Cardiovascular · 141d
Cleared Nov 27, 1991
3M ANTI-CARDIOLIPIN FAST(TM) TEST
K913054 · MID
3M Diagnostic Systems, Inc.
Immunology · 141d
Cleared Nov 27, 1991
ACS ULTRA-2 THROMBOPLASTIN
K913250 · GJS
Analytical Control Systems, Inc.
Hematology · 128d
Cleared Nov 27, 1991
MX927 BLOOD TRANSFER DEVICE
K913498 · FMI
Medex, Inc.
General Hospital · 113d
Cleared Nov 27, 1991
ECAT SCANNER (MODEL 921)
K913637 · KPS
Cti Pet Systems, Inc.
Radiology · 104d
Cleared Nov 27, 1991
REP(R) SPE TEMPLATE 30, 16, & 8
K913807 · CEF
Helena Laboratories
Chemistry · 93d
Cleared Nov 27, 1991
INFINITY(TM) MICROTAPER HIP SYSTEM
K913874 · JDI
Dow Corning Wright
Orthopedic · 90d
Cleared Nov 27, 1991
BARD(R) BIOPOTENTIAL AMPLIFIER II
K913875 · DRQ
Bard Electrophysiology
Cardiovascular · 90d
Cleared Nov 27, 1991
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
K913879 · JPK
R&D Systems, Inc.
Hematology · 90d
Cleared Nov 27, 1991
REFURBISHED ORTHODONTIC APPLIANCES
K913913 · EJF
Ortho-Cycle Co.
Dental · 89d