FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89497–89520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1998
SEMKIN BIPOLAR FORCEP
K974594 · HTD
Titan Mfg., Inc.
General & Plastic Surgery · 197d
Cleared Jun 24, 1998
CUSHING BAYONET, INSULATED BIPOLAR FORCEP
K974595 · HTD
Titan Mfg., Inc.
General & Plastic Surgery · 197d
Cleared Jun 24, 1998
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL
K974735 · JOS
Aaron Medical Industries
General & Plastic Surgery · 188d
Cleared Jun 24, 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
K980591 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 127d
Cleared Jun 24, 1998
UNIVERSAL DRIVE SYSTEM
K981269 · HRX
Linvatec Corp.
Orthopedic · 78d
Cleared Jun 24, 1998
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
K981416 · GEI
Magna Advanced Technologies, Inc.
General & Plastic Surgery · 65d
Cleared Jun 24, 1998
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K981779 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 35d
Cleared Jun 24, 1998
DRS SYSTEM
K981822 · ITH
Professional Distribution Systems, Inc.
Physical Medicine · 33d
Cleared Jun 24, 1998
OLYMPUS CALCIUM ARSENAZO III REAGENT
K982035 · CJY
Olympus Diagnostica GmbH
Chemistry · 14d
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