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
89305–89328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1998
LYSONIX SUCTION LIPOPLASTY SYSTEM
K980771 · QPB
Lysonix, Inc.
General & Plastic Surgery · 136d
Cleared Jul 13, 1998
HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR
K980787 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 133d
Cleared Jul 13, 1998
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K981351 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Jul 13, 1998
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402
K981352 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 90d
Cleared Jul 13, 1998
ARTOSCAN S
K981358 · LHN
Biosound Esaote, Inc.
Radiology · 90d
Cleared Jul 13, 1998
POWERSTAR BIPOLAR SCISSORS
K981361 · GEI
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jul 13, 1998
DEPUY GLOBAL SHOULDER GLENOID
K981487 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 13, 1998
SUTURE PLACEMENT DEVICE AND ACCESSORIES
K981531 · GCJ
Lsi Solutions
General & Plastic Surgery · 75d
Cleared Jul 13, 1998
SURGILON, DERMALON, & OPHTHALON
K981582 · GAR
Davis & Geck, Inc.
General & Plastic Surgery · 70d
Cleared Jul 13, 1998
ANSPACH SUTURE ANCHOR
K981688 · MBI
The Anspach Effort, Inc.
Orthopedic · 63d
Cleared Jul 13, 1998
LM ANCHOR
K981755 · MBI
Li Medical Technologies, Inc.
Orthopedic · 56d
Cleared Jul 13, 1998
LM ANCHOR
K981764 · MBI
Li Medical Technologies, Inc.
Orthopedic · 55d
Cleared Jul 13, 1998
LORENZ PECTUS SUPPORT BAR STABILIZER
K981789 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 54d
Cleared Jul 13, 1998
LACTOSORB POP RIVET
K981798 · JDR
Biomet, Inc.
Orthopedic · 53d
Cleared Jul 13, 1998
MAGNETIC PORT SILICONE TISSUE EXPANDER
K982067 · LCJ
Specialty Surgical Products, Inc.
General & Plastic Surgery · 31d
Cleared Jul 13, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982154 · MNI
Danek Medical, Inc.
Orthopedic · 24d
Cleared Jul 13, 1998
PRESSURE TRANSDUCER AIRFLOW SENSOR
K982293 · MNR
Pro-Tech Services, Inc.
Anesthesiology · 12d
Cleared Jul 10, 1998
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
K971971 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 407d
Cleared Jul 10, 1998
CPAP HUMIDIFIER (HC 200)
K973161 · BZD
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 322d
Cleared Jul 10, 1998
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
K974415 · JOJ
Kimberly-Clark Corp.
General Hospital · 228d
Cleared Jul 10, 1998
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
K974652 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 210d
Cleared Jul 10, 1998
NEUROMETRIC ANALYSIS SYSTEM
K974748 · OLU
Nxlink, Ltd.
Neurology · 203d
Cleared Jul 10, 1998
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
K974763 · HET
Deroyal Industries, Inc.
Obstetrics & Gynecology · 203d
Cleared Jul 10, 1998
LAKE REGION MANUFACTURING GUIDEWIRES
K981326 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 88d