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
88993–89016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1998
RAICHEM CO2 REAGENT
K982056 · KHS
Reagents Applications, Inc.
Chemistry · 15d
Cleared Jun 24, 1998
VENTURI VENTILATOR
K982174 · CBK
Cardiopulmonary Corp.
Anesthesiology · 7d
Cleared Jun 23, 1998
PURESPERM
K980814 · MQL
Nidacon International AB
Obstetrics & Gynecology · 112d
Cleared Jun 23, 1998
AUTOMATED CORNEAL TREPHINE
K981063 · HRG
Laser Center Dev. Corp.
Ophthalmic · 92d
Cleared Jun 23, 1998
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
K981103 · HQC
Alcon Laboratories
Ophthalmic · 89d
Cleared Jun 23, 1998
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS...
K981252 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 78d
Cleared Jun 23, 1998
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC...
K981265 · LOS
Hewlett-Packard Co.
Cardiovascular · 77d
Cleared Jun 23, 1998
CARESIDE TOTAL BILIRUBIN
K981588 · CIG
Careside, Inc.
Chemistry · 50d
Cleared Jun 23, 1998
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
K982127 · CAH
Porous Media Corp.
General Hospital · 6d
Cleared Jun 22, 1998
KSEA CALCUSON
K973251 · FEO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 297d
Cleared Jun 22, 1998
X-CELL WOUND DRESSING
K974251 · MGQ
Xylos Corporation
General & Plastic Surgery · 221d
Cleared Jun 22, 1998
HYDROTONE
K974321 · ILJ
North American Technical Services Corp.
Physical Medicine · 217d
Cleared Jun 22, 1998
PHOTONIC STIMULATOR
K974468 · ILY
Bales Scientific, Inc.
Physical Medicine · 208d
Cleared Jun 22, 1998
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
K981075 · MQN
Synthes (Usa)
Dental · 90d
Cleared Jun 22, 1998
SOLOSITE GEL CONFORMABLE DRESSING
K981150 · MGQ
Smith & Nephew, Inc.
General & Plastic Surgery · 83d
Cleared Jun 22, 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING,...
K981151 · LPN
Alcon Laboratories
Ophthalmic · 84d
Cleared Jun 22, 1998
ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018,...
K981166 · KNW
Inrad
Gastroenterology & Urology · 83d
Cleared Jun 22, 1998
SHARPTRACK REUSABLE SHARPS CONTAINER
K981184 · FMI
Bfi- Medical Waste Systems
General Hospital · 82d
Cleared Jun 22, 1998
HOWMEDICA SCN NAIL
K981261 · HSB
Howmedica Corp.
Orthopedic · 76d
Cleared Jun 22, 1998
NITRILON CORRECT-TOUCH
K981304 · LZA
Ct Intl.
General Hospital · 73d
Cleared Jun 22, 1998
OSTEO I-C HUMERAL NAIL SYSTEM
K981309 · HSB
Osteonics Corp.
Orthopedic · 73d
Cleared Jun 22, 1998
NITRILON CORRECT-TOUCH
K981333 · LZA
Biopro (M) Sdn Bhd
General Hospital · 70d
Cleared Jun 22, 1998
INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM
K981340 · MAI
Innovasive Devices, Inc.
Orthopedic · 70d
Cleared Jun 22, 1998
AMM
K981467 · JIF
Abbott Laboratories
Chemistry · 60d