FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95017–95040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1997
SEALITE SCIENCES, INC. AQUALITE PROLACTIN
K970188 · CFT
Sealite Sciences, Inc.
Chemistry · 34d
Cleared Feb 20, 1997
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
K970198 · DHN
Scimedx Corp.
Immunology · 30d
Cleared Feb 20, 1997
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
K970396 · JIW
Dade Chemistry Systems, Inc.
Chemistry · 17d
Cleared Feb 19, 1997
COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER
K940942 · IYO
Medison America, Inc.
Radiology · 1086d
Cleared Feb 19, 1997
ANTERIOR DYNAMIZED SYSTEM
K953978 · KWQ
Acromed Corp.
Orthopedic · 546d
Cleared Feb 19, 1997
ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
K961073 · IYO
Atlantis Diagnostics Intl., Inc.
Radiology · 338d
Cleared Feb 19, 1997
SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH...
K962702 · GCJ
General Surgical Innovations
General & Plastic Surgery · 222d
Cleared Feb 19, 1997
NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
K964305 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 113d
Cleared Feb 19, 1997
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
K964665 · DSY
Carbomedics, Inc.
Cardiovascular · 90d
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