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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
136897–136920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1988
MODEL 5050 SURGILASER FOR PULMONARY USE
K871876 · LLO
Lasermatic, Inc.
Anesthesiology · 253d
Cleared Jan 22, 1988
MODEL 5050 SURGILASER FOR NEUROSURGERY USE
K871933 · GEX
Lasermatic, Inc.
General & Plastic Surgery · 248d
Cleared Jan 22, 1988
AMASTIM 2000
K872704 · GZJ
Amatech International, Inc.
Neurology · 199d
Cleared Jan 22, 1988
AMOX OXYGEN GENERATORS
K873156 · CAW
Vbm Corp.
Anesthesiology · 175d
Cleared Jan 22, 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · CBK
Puritan Bennett Corp.
Anesthesiology · 168d
Cleared Jan 22, 1988
CBG CUFF MANOMETER
K873614 · BSK
Bio-Med Devices, Inc.
Anesthesiology · 136d
Cleared Jan 22, 1988
MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY
K873790 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 126d
Cleared Jan 22, 1988
MODIFIED STRESS MACHINE
K873819 · ISA
S.J.F., Inc.
Physical Medicine · 123d
Cleared Jan 22, 1988
INTERFERENTIAL CURRENT UNIT
K874119 · LIH
Compustim Electronics
Neurology · 100d
Cleared Jan 22, 1988
BIO-COR II COLLAGEN CORNEAL SHIELD
K874224 · MOE
Bausch & Lomb, Inc.
Ophthalmic · 98d
Cleared Jan 22, 1988
BIO-COR EXT COLLAGEN CORNEAL SHIELD
K874225 · MOE
Bausch & Lomb, Inc.
Ophthalmic · 98d
Cleared Jan 22, 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418 · BTM
Life Support Products, Inc.
Anesthesiology · 86d
Cleared Jan 22, 1988
USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R)
K874506 · JGJ
Technicon Instruments Corp.
Chemistry · 81d
Cleared Jan 22, 1988
ENVINET(TM)
K874551 · EFQ
Marion Laboratories, Inc.
General & Plastic Surgery · 79d
Cleared Jan 22, 1988
ENVISAN PAD
K874552 · KOZ
Marion Laboratories, Inc.
General & Plastic Surgery · 79d
Cleared Jan 22, 1988
DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE
K874735 · GXY
Dantec Electronics, Inc.
Neurology · 65d
Cleared Jan 22, 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
K874736 · IPF
Rich-Mar Corp.
Physical Medicine · 65d
Cleared Jan 22, 1988
DEY-PAK PURIFIED WATER, USP, STERILE
K875011 · CCQ
Dey Laboratories, Inc.
Anesthesiology · 49d
Cleared Jan 22, 1988
GHAJAR GUIDE SYSTEM FOR THE PERFORATOR
K875019 · HBF
Neurodynamics, Inc.
Neurology · 49d
Cleared Jan 22, 1988
DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP
K875024 · CCQ
Dey Laboratories, Inc.
Anesthesiology · 49d
Cleared Jan 22, 1988
RONGEUR (NEUROSURGICAL INSTRUMENTS)
K875043 · HAE
Solway, Inc.
Neurology · 51d
Cleared Jan 22, 1988
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
K875164 · DFH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Jan 22, 1988
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165 · DEH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Jan 22, 1988
DISPOSABLE SURGICAL FACE MASK
K875172 · FXX
Irema USA , Ltd.
General Hospital · 36d