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
103945–103968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1995
SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION
K945428 · LLZ
Multi-Dimensional Imaging, Inc.
Radiology · 125d
Cleared Mar 09, 1995
FUJI MEDICAL LASER IMAGER FL-IM D
K945475 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 121d
Cleared Mar 09, 1995
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · LCQ
Roche Diagnostic Systems, Inc.
Toxicology · 119d
Cleared Mar 09, 1995
REUSABLE MONOPOLAR FORCEPS
K950877 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 10d
Cleared Mar 08, 1995
TRAV-LER KIT
K943942 · JEQ
John O. Butler Co.
Dental · 208d
Cleared Mar 08, 1995
TCD OR TCD NEUROPATHY STAR
K944234 · GWI
Jcm Management & Planning Co.
Neurology · 189d
Cleared Mar 08, 1995
BRANEMARK SYSTEM 3.3MM FIXTURE
K944683 · DZE
Nobelpharma USA, Inc.
Dental · 167d
Cleared Mar 08, 1995
URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY
K944972 · EXY
Myo/Kinetic Systems, Inc.
Gastroenterology & Urology · 148d
Cleared Mar 08, 1995
URO-FLO
K945140 · LJH
Mallinckrodt Group, Inc.
Gastroenterology & Urology · 139d
Cleared Mar 08, 1995
LSVP INTERNATIONAL GRASPING FORCEPS
K945295 · LQR
Lsvp Intl., Inc.
Gastroenterology & Urology · 128d
Cleared Mar 08, 1995
ALTREX(R) 200 HEMODIALYZER
K945595 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 114d
Cleared Mar 08, 1995
ALTRES(R) 140 HEMODIALYZER
K945596 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 114d
Cleared Mar 08, 1995
ALTRES(R) 170 HEMODIALYZER
K945597 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 114d
Cleared Mar 08, 1995
NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE...
K945947 · DXN
Nellcor, Inc.
Cardiovascular · 92d
Cleared Mar 08, 1995
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
K946043 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 86d
Cleared Mar 08, 1995
FRANCE ORTHODONTIE
K950121 · DZB
France Orthodontie
Dental · 55d
Cleared Mar 08, 1995
FUJI ORTHO LC
K950556 · DYH
GC America, Inc.
Dental · 29d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)
K933784 · MID
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST
K933786 · MID
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
K933788 · MID
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Mar 07, 1995
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
K934515 · LPH
Zimmer, Inc.
Orthopedic · 538d
Cleared Mar 07, 1995
NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR
K940739 · MOD
Newport Medical Instruments, Inc.
Anesthesiology · 383d
Cleared Mar 07, 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)
K943254 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 244d
Cleared Mar 07, 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (UNBEADED)
K943255 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 244d