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
118345–118368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1992
GLASION VARNISH
K915376 · FMC
Sci-Pharm Scientific Pharmaceutical,...
General Hospital · 54d
Cleared Jan 22, 1992
QUICKIE CARBON WHEELCHAIR
K915533 · IOR
Sunrise Medical Quickie Designs, Inc.
Physical Medicine · 43d
Cleared Jan 22, 1992
MODEL 3587A RESUME II LEAD
K915540 · GZF
Medtronic Vascular
Neurology · 43d
Cleared Jan 22, 1992
INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET
K915708 · CEO
Tech Intl. Co.
Chemistry · 54d
Cleared Jan 21, 1992
LABOR DELIVERY TRAY
K912054 · HFW
Medical Device Inspection Co., Inc.
Obstetrics & Gynecology · 257d
Cleared Jan 21, 1992
HYPERFREE
K913527 · BYO
Kist Intl.
Anesthesiology · 166d
Cleared Jan 21, 1992
THORACIC CATHTER STYLET
K913539 · GBX
Intl. Medical Devices , Ltd.
General & Plastic Surgery · 165d
Cleared Jan 21, 1992
THORACIC CATHETER WITH GUIDE
K913542 · GBX
Intl. Medical Devices , Ltd.
General & Plastic Surgery · 165d
Cleared Jan 21, 1992
BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV
K913915 · DTN
Bard Cardiosurgery Div
Cardiovascular · 140d
Cleared Jan 21, 1992
HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES
K914980 · BYX
Medical Fittings, Inc.
Anesthesiology · 76d
Cleared Jan 21, 1992
DOHLMAN DOANE KERATOPROTHESIS
K915062 · HQM
Mackeen Consultants, Ltd.
Ophthalmic · 74d
Cleared Jan 21, 1992
TOUCH 'N HEAT MODEL 5002, MODIFICATION
K915243 · EKM
Analytic Technology
Dental · 82d
Cleared Jan 21, 1992
SILICOATER SYSTEM
K915335 · EBF
Heraeus Kulzer, Inc.
Dental · 56d
Cleared Jan 21, 1992
THREE WHEEL SCOOTER
K915659 · INI
Pride Health Care, Inc.
Physical Medicine · 34d
Cleared Jan 21, 1992
RIHARDS TITANIUM HALF PIN
K920024 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 19d
Cleared Jan 17, 1992
VITA CEREC SET AND VITA CEREC BLOCS
K895901 · ELW
Vident
Dental · 833d
Cleared Jan 17, 1992
DIA ANATOMIC ABUTMENT
K902433 · DZE
Dental Imaging Assoc., Inc.
Dental · 596d
Cleared Jan 17, 1992
CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4
K910624 · LLN
Wr Medical Electronics Co.
Neurology · 339d
Cleared Jan 17, 1992
EXCEL MODEL 2110
K910727 · GZJ
Excel Medical Systems, Inc.
Neurology · 331d
Cleared Jan 17, 1992
LEOCOR GUIDING CATHETER
K911270 · DQO
Leocor, Inc.
Cardiovascular · 301d
Cleared Jan 17, 1992
OCCLUDE
K912632 · EFH
Pascal Co., Inc.
Dental · 217d
Cleared Jan 17, 1992
TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS
K913949 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 130d
Cleared Jan 17, 1992
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
K913956 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 134d
Cleared Jan 17, 1992
CORRECT-S.I.M.
K914437 · ELW
Jeneric/Pentron, Inc.
Dental · 105d