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
88801–88824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 10, 1998
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM
K981346 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 87d
Cleared Jul 10, 1998
MICROCOOL SURGICAL GOWN
K981393 · FYA
Kimberly-Clark Corp.
General Hospital · 84d
Cleared Jul 10, 1998
HEART CATH TRAY, STERILE, DISPOSABLE
K981441 · DQO
Trinity Laboratories, Inc.
Cardiovascular · 80d
Cleared Jul 10, 1998
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
K981464 · KNF
Omnitech Systems, Inc.
Obstetrics & Gynecology · 78d
Cleared Jul 10, 1998
TEMPO III
K981509 · LGZ
Medical Products, Inc.
General Hospital · 73d
Cleared Jul 10, 1998
PRILANE
K981524 · EIH
Gresco Products, Inc.
Dental · 73d
Cleared Jul 10, 1998
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER...
K981698 · MOI
Chiron Corp.
Immunology · 57d
Cleared Jul 10, 1998
PERMACEM AUTOMIX LUTING CEMENT SYSTEM
K981813 · EBF
Foremost Dental Mfg., Inc.
Dental · 49d
Cleared Jul 10, 1998
CONVERTORS TRILAMINATE DRAPES
K981818 · KKX
Allegiance Healthcare Corp.
General Hospital · 49d