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
88369–88392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1998
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · LEG
Dade Behring, Inc.
Toxicology · 11d
Cleared Aug 24, 1998
MAGELLAN
K961903 · HAW
Biosense, Ltd.
Neurology · 830d
Cleared Aug 24, 1998
PEGASUS ND:YAG LASER SYSTEM
K980559 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 192d
Cleared Aug 24, 1998
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K980725 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 181d
Cleared Aug 24, 1998
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 175d
Cleared Aug 24, 1998
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
K981272 · MQX
Electro Therapeutic Devices, Inc.
General Hospital · 139d
Cleared Aug 24, 1998
SUCTION CATHETER
K981910 · BSY
Ni-Med, Inc.
Anesthesiology · 84d
Cleared Aug 24, 1998
THE SNORE PEACE
K981923 · LRK
The Snore Peace Group
Dental · 84d
Cleared Aug 24, 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · EIA
Welch Allyn, Inc.
Dental · 83d
Cleared Aug 24, 1998
BREATHERITE
K981944 · CAF
Ventlab Corp.
Anesthesiology · 82d
Cleared Aug 24, 1998
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR...
K981971 · CBK
Bird Products Corp.
Anesthesiology · 81d
Cleared Aug 24, 1998
REACH HIP COMPONENT
K982367 · LPH
Biomet, Inc.
Orthopedic · 48d
Cleared Aug 24, 1998
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · FYC
Allegiance Healthcare Corp.
General Hospital · 48d
Cleared Aug 24, 1998
MITEK MICRO ANCHOR
K982420 · JDR
Mitek Products
Orthopedic · 70d
Cleared Aug 24, 1998
AMALCAP PLUS
K982456 · EJJ
Ab Ardent
Dental · 40d
Cleared Aug 24, 1998
VIVALLOY HR
K982458 · EJJ
Ab Ardent
Dental · 40d
Cleared Aug 24, 1998
VIVACAP HR
K982460 · EJJ
Ab Ardent
Dental · 40d
Cleared Aug 24, 1998
GLASIONOMER CEMENT CX PLUS
K982461 · EMA
Shofu Dental Corp.
Dental · 40d
Cleared Aug 24, 1998
TOKUYAMA SOFRELINER
K982537 · EBI
Tokuyama America, Inc.
Dental · 34d
Cleared Aug 24, 1998
MPS FIXED FLOW RATE SET
K982587 · FPA
Medical Product Specialists
General Hospital · 31d
Cleared Aug 24, 1998
AIRDENT RADIANCE CURING LIGHT
K982615 · EBZ
Air Techniques, Inc.
Dental · 28d
Cleared Aug 24, 1998
SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K982730 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 39d
Cleared Aug 21, 1998
ELECTROCARDIOGRAPHS
K972587 · LOS
Dr. Lee Co., Ltd.
Cardiovascular · 406d
Cleared Aug 21, 1998
SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
K974269 · IYN
Medison America, Inc.
Radiology · 281d