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
92929–92952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1997
STONE EXTRACTOR
K971123 · OCZ
Phx Technologies Corp.
Gastroenterology & Urology · 92d
Cleared Jun 27, 1997
DEFEND FLUID RESISTANT PLEATED MASK
K971130 · FXX
Carl Parker Associates, Inc.
General Hospital · 92d
Cleared Jun 27, 1997
RAND SURGICAL SPONGE
K971178 · EFQ
Trans Aire
General & Plastic Surgery · 88d
Cleared Jun 27, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE...
K971188 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 88d
Cleared Jun 27, 1997
ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971282 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 81d
Cleared Jun 27, 1997
LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
K971293 · FPA
Abbott Mfg., Inc.
General Hospital · 81d
Cleared Jun 27, 1997
AMSCO SURGICAL TABLE
K971307 · FQO
STERIS Corporation
General & Plastic Surgery · 80d
Cleared Jun 27, 1997
PYLORISET EIA-G (68926)
K971537 · LYR
Orion Diagnostica, Div. Orion Corp.
Microbiology · 60d
Cleared Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · DHR
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 27, 1997
SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES
K971665 · LZA
Sj Medical Products (M) Sdn Bhd
General Hospital · 52d
Cleared Jun 27, 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676 · HRX
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Jun 27, 1997
J-FX CERCLAGE SYSTEM
K971682 · LRN
Johnson & Johnson Professionals, Inc.
Orthopedic · 52d
Cleared Jun 27, 1997
OSTEOPOWER SYSTEM AND ACCESSORIES
K971692 · KMW
Osteomed Corp.
Dental · 51d
Cleared Jun 27, 1997
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971716 · LAR
Bayer Corp.
Chemistry · 49d
Cleared Jun 27, 1997
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME...
K971753 · DWM
Denver Biomaterials, Inc.
Anesthesiology · 46d
Cleared Jun 27, 1997
OSTEO SMALL AND MINI BONE SCREWS
K971778 · HWC
Osteonics Corp.
Orthopedic · 44d
Cleared Jun 26, 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE...
K963732 · JOH
Mallinckrodt Medical
Anesthesiology · 282d
Cleared Jun 26, 1997
THERATRON 780E
K964606 · IWB
Theratronics, Inc.
Radiology · 220d
Cleared Jun 26, 1997
BAIR HUGGER MODEL 630 CARDIAC BLANKET
K964673 · DWJ
Augustine Medical, Inc.
Cardiovascular · 217d
Cleared Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716 · GGN
American Bioproducts Co.
Hematology · 213d
Cleared Jun 26, 1997
STA-LIATEST D-DI TEST KIT
K964728 · DAP
American Bioproducts Co.
Hematology · 213d
Cleared Jun 26, 1997
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
K964969 · MOS
GE Medical Systems
Radiology · 196d
Cleared Jun 26, 1997
ESCORT LINK CENTRAL STATION MONITOR
K970012 · DSI
Medical Data Electronics
Cardiovascular · 175d
Cleared Jun 26, 1997
CLINICATH IR PERIPHERALLY INSERTED CATHETER
K970269 · LJS
Sims Deltec, Inc.
General Hospital · 154d