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
122113–122136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1991
BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
K910196 · FGH
C.R. Bard, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 27, 1991
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110
K910308 · ITY
Inmark Corp.
Radiology · 62d
Cleared Mar 27, 1991
SUTURE REMOVAL KIT
K910361 · MCZ
Megadyne Medical Products, Inc.
General & Plastic Surgery · 57d
Cleared Mar 27, 1991
SLT MICROPLATE WASHER
K910740 · JJQ
Tecan U.S., Ltd.
Chemistry · 34d
Cleared Mar 26, 1991
NAMIC CONTRAST SAVINGS DELIVERY SYSTEM
K903493 · IZI
North American Instrument Corp.
Radiology · 235d
Cleared Mar 26, 1991
DEVILBISS MODEL 7352 SERIES
K904766 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 155d
Cleared Mar 26, 1991
L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC
K904901 · ITX
Parexel Intl. Corp.
Radiology · 147d
Cleared Mar 26, 1991
SMA 26 TRANSDUCER
K904902 · ITX
Parexel Intl. Corp.
Radiology · 147d
Cleared Mar 26, 1991
JETTA JR. HYDRO MASSAGE
K905599 · ILJ
Jetta Products, Inc.
Physical Medicine · 103d
Cleared Mar 26, 1991
ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)
K905785 · HRX
Orthoconcept, Inc.
Orthopedic · 97d
Cleared Mar 26, 1991
GLOBAL TOTAL SHOULDER
K905786 · KWT
Depuy, Inc.
Orthopedic · 89d
Cleared Mar 26, 1991
NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON
K910019 · CCK
Novametrix Medical Systems, Inc.
Anesthesiology · 82d
Cleared Mar 26, 1991
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
K910464 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 50d
Cleared Mar 26, 1991
PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
K910755 · MEH
Intermedics Orthopedics
Orthopedic · 39d
Cleared Mar 26, 1991
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
K910988 · JDI
Osteonics Corp.
Orthopedic · 19d
Cleared Mar 26, 1991
QUAD-LINK RETRACTABLE MOUNT
K911152 · ITI
Tarsys Engineering, Inc.
Physical Medicine · 11d
Cleared Mar 25, 1991
OWENS CATHETER
K896520 · LIT
Boston Scientific Corp
Cardiovascular · 495d
Cleared Mar 25, 1991
DYNAMIC SPECTRAL PHONOCARDIOGRAPH
K902185 · DQC
Reeves Scientific, Inc.
Cardiovascular · 315d
Cleared Mar 25, 1991
DIAGNOSTIC INTRASCULAR CATHETER
K903848 · DQO
Applied Vascular Devices, Inc.
Cardiovascular · 216d
Cleared Mar 25, 1991
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)
K904410 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 180d
Cleared Mar 25, 1991
ES/ULTRA DISPLAY AND PROCESSING STATION
K905412 · IYX
Toshiba America Medical Systems, In.C
Radiology · 112d
Cleared Mar 25, 1991
VESSEL DILATOR
K905416 · DRE
The R Group
Cardiovascular · 111d
Cleared Mar 25, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL
K910220 · LNH
Toshiba America Mri, Inc.
Radiology · 67d
Cleared Mar 25, 1991
MAGNETOM 42 SP AND 63 SP
K910498 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 48d