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
90337–90360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1998
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · KCT
Kimberly-Clark Corp.
General Hospital · 127d
Cleared Feb 11, 1998
VERSASTAT MULTIPOLAR SCISSORS AND CABLES
K974250 · GEI
Pilling Weck, Inc.
General & Plastic Surgery · 90d
Cleared Feb 11, 1998
0.2 U BACTERIAL FILTER
K974661 · FPB
Sims Deltec, Inc.
General Hospital · 58d
Cleared Feb 11, 1998
POWDERFREE LATEX EXAMINATION GLOVES
K974832 · LYY
Servicom Services Sdn Bhd
General Hospital · 49d
Cleared Feb 10, 1998
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)
K973225 · FLE
Getinge/Castle, Inc.
General Hospital · 167d
Cleared Feb 10, 1998
MASKY
K973542 · EBI
Pressing DI Monticelli Rag. Stefano
Dental · 145d
Cleared Feb 10, 1998
PALJET-B
K973663 · DRX
Golden Gate Bio-Device
Cardiovascular · 138d
Cleared Feb 10, 1998
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM
K973867 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 141d
Cleared Feb 10, 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 90d
Cleared Feb 10, 1998
LS-905 FIBERCHOICE ADAPTER SYSTEM
K974229 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 90d
Cleared Feb 10, 1998
AMPLAID AM50
K974235 · ETY
Amplifon S.P.A.
Ear, Nose, Throat · 90d
Cleared Feb 10, 1998
GSI 70 AUDIOPATH SCREENER
K974237 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Feb 10, 1998
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM
K974239 · IXI
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Feb 10, 1998
40 CC GRANDE
K974247 · DSP
Boston Scientific Corp
Cardiovascular · 90d
Cleared Feb 10, 1998
FM RECEIVER - AUDITORY TRAINER
K974287 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 88d
Cleared Feb 10, 1998
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
K974295 · KGZ
Byron Medical
General & Plastic Surgery · 88d
Cleared Feb 10, 1998
LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
K974323 · HIS
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 84d
Cleared Feb 10, 1998
BALDUR NON-STERILE COTTON SPONGES
K974347 · EFQ
Baldur Systems Corp.
General & Plastic Surgery · 83d
Cleared Feb 10, 1998
FRIALIT -2 SCREW
K974358 · DZE
Friatec AG
Dental · 83d
Cleared Feb 10, 1998
FRIALIT-2 CYLINDER
K974359 · DZE
Friatec AG
Dental · 83d
Cleared Feb 10, 1998
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K974381 · GEX
Candela Corp.
General & Plastic Surgery · 82d
Cleared Feb 10, 1998
STERILE SALINE FOR CATHETER CARE
K974397 · JOL
Baxter Healthcare Corp
General Hospital · 81d
Cleared Feb 10, 1998
ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
K974484 · GEI
Ximed/Prosure/Injectx
General & Plastic Surgery · 76d
Cleared Feb 10, 1998
RENAMEL FLOWABLE COMPOSITE
K974494 · EBD
Cosmedent, Inc.
Dental · 74d