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
94513–94536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1997
DORNIER MEDILAS FIBER TOME LASER
K964760 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 84d
Cleared Feb 19, 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 82d
Cleared Feb 19, 1997
RMI DUAL FLUID IRRIGATING SYRINGE
K964833 · KYZ
Research Medical, Inc.
General Hospital · 79d
Cleared Feb 19, 1997
STABLELOC II EXTERNAL FIXATOR
K965029 · JEC
Acu Med, Inc.
Orthopedic · 64d
Cleared Feb 19, 1997
BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
K970110 · ODC
Bard Medical Div.
Gastroenterology & Urology · 37d
Cleared Feb 19, 1997
PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
K970346 · LZO
Kairos Orthopaedics
Orthopedic · 20d
Cleared Feb 18, 1997
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · KYF
Pharmacia Iovision, Inc.
Ophthalmic · 447d
Cleared Feb 18, 1997
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR...
K960363 · MJT
Biomet, Inc.
Orthopedic · 390d
Cleared Feb 18, 1997
STRATEC LIA II ANALYZER
K961142 · JJE
Nichols Institute Diagnostics
Hematology · 334d
Cleared Feb 18, 1997
OLYMPUS ACID PHOSPHATASE REAGENT
K963640 · CKB
Olympus America, Inc.
Chemistry · 159d
Cleared Feb 18, 1997
ACCUCURE 3000
K964486 · GEX
Lasermed, Inc.
General & Plastic Surgery · 102d
Cleared Feb 18, 1997
PROTECT ALL BLOOD PRESSURE CUFF COVER
K964648 · DXQ
Protect All, Inc.
Cardiovascular · 90d
Cleared Feb 18, 1997
MODELS EXL AND EXS EXTREMITY COIL SET
K964668 · MOS
Mri Devices Corp.
Radiology · 89d
Cleared Feb 18, 1997
RAPISEAL PATCH
K964857 · FTL
Fusion Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Feb 18, 1997
VITROS CHEMISTRY PRODUCTS UPRO SLIDES
K964960 · JGP
Johnson & Johnson Clinical...
Chemistry · 69d
Cleared Feb 18, 1997
ELECSYS ESTRADIOL ASSAY
K965109 · CHP
Boehringer Mannheim Corp.
Chemistry · 60d
Cleared Feb 18, 1997
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR...
K965111 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 18, 1997
ALT/SGPT
K965134 · CKA
Derma Media Lab., Inc.
Chemistry · 57d
Cleared Feb 18, 1997
SAS SERUM/URINE HCG
K965250 · JHI
Sascie
Chemistry · 64d
Cleared Feb 18, 1997
SAS PREGNANCY STRIP
K965253 · JHI
Sascie
Chemistry · 64d
Cleared Feb 18, 1997
ADVANCED QUALITY PREGNANCY TEST
K970008 · LCX
Bionike, Inc.
Chemistry · 47d
Cleared Feb 18, 1997
UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE
K970066 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 41d
Cleared Feb 18, 1997
THYROID CALIBRATOR
K970389 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 15d
Cleared Feb 14, 1997
VENTANA ANTI-CD4 PRIMARY ANTIBODY
K941604 · DEH
Ventana Medical Systems, Inc.
Immunology · 1050d