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
104929–104952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1995
OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY...
K944704 · GEX
Xintec Corporation
General & Plastic Surgery · 105d
Cleared Jan 06, 1995
THERAPEP
K944900 · BWF
Dhd Diemolding Healthcare Div.
Anesthesiology · 94d
Cleared Jan 06, 1995
OPTILITE VI FIBEROPTIC ACCESSORIES
K944965 · GEX
Xintec Corporation
General & Plastic Surgery · 87d
Cleared Jan 05, 1995
VIBA-BRUSH
K933870 · HHT
Rovers B.V.
Obstetrics & Gynecology · 517d
Cleared Jan 05, 1995
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · BTM
Respironics, Inc.
Anesthesiology · 462d
Cleared Jan 05, 1995
ALGO-2 NEWBORN HEARING SCREENER
K936039 · GWJ
Natus Medical, Inc.
Neurology · 381d
Cleared Jan 05, 1995
ELECTRIC VACUM PUMP
K941096 · BTA
Impact Instrumentation, Inc.
General & Plastic Surgery · 304d
Cleared Jan 05, 1995
DST-XL
K942837 · KPS
Sopha Medical Systems, Inc.
Radiology · 204d
Cleared Jan 05, 1995
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
K943380 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 176d
Cleared Jan 05, 1995
CALCIUM REAGENT
K944258 · CIC
Olympus America, Inc.
Chemistry · 126d
Cleared Jan 05, 1995
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
K944858 · DSY
Baxter Edwards
Cardiovascular · 94d
Cleared Jan 05, 1995
PECTACLE FRAMES AND/OR SUNGLASSES
K945147 · HQY
Mi MI Progress Co. , Ltd.
Ophthalmic · 77d
Cleared Jan 05, 1995
IRMA BLOOD ANALYSIS SYSTEM
K945240 · CHL
Diametrics Medical, Inc.
Chemistry · 70d
Cleared Jan 05, 1995
TOP ACOM STATION
K945293 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Jan 05, 1995
CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO...
K945655 · CGX
Miles, Inc.
Chemistry · 49d
Cleared Jan 05, 1995
VETTA LIGHTWEIGHT CYCLING EYEWEAR
K945683 · HQY
Shaw, Pittman, Potts & Trowbridge
Ophthalmic · 45d
Cleared Jan 05, 1995
SUNLGASSES, SPORT SUNGLASSES & FISHING GLASSES
K945735 · HQY
Shu Gie Industrial Co., Ltd.
Ophthalmic · 43d
Cleared Jan 05, 1995
SUNGLASSES
K945817 · HQY
Walmart Stores
Ophthalmic · 38d
Cleared Jan 05, 1995
SUNGLASSES
K945818 · HQY
Walmart Stores
Ophthalmic · 38d
Cleared Jan 05, 1995
SUNGLASSES
K945819 · HQY
Walmart Stores
Ophthalmic · 38d
Cleared Jan 05, 1995
BUNNY SUNGLASSES
K945840 · HQY
Tony (U.S.A.), Inc.
Ophthalmic · 36d
Cleared Jan 05, 1995
ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA
K946002 · GEX
Origin Medsystems, Inc.
General & Plastic Surgery · 44d
Cleared Jan 04, 1995
SIEMENS QUANTUM 7E11 TRANSRECTAL TRANSDUCER
K930052 · ITX
Siemens Quantum, Inc.
Radiology · 728d
Cleared Jan 04, 1995
GODAT UTERINE MANIPULATOR INJECTOR
K935023 · LKF
Ideas For Medicine, Inc.
Obstetrics & Gynecology · 441d