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
93433–93456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1997
HI DENSE TC
K971927 · EMA
Shofu Dental Corp.
Dental · 34d
Cleared Jun 30, 1997
RCT GEL ROOT CANAL THERAPY GEL
K972234 · EIC
Dentsply Intl.
Dental · 14d
Cleared Jun 27, 1997
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K963160 · PKL
Olympus America, Inc.
Gastroenterology & Urology · 317d
Cleared Jun 27, 1997
ENDOSCOPE
K964131 · FAM
Akos Biomedical, Inc.
Gastroenterology & Urology · 255d
Cleared Jun 27, 1997
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS...
K965002 · LZO
Encore Orthopedics, Inc.
Orthopedic · 193d
Cleared Jun 27, 1997
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE...
K970720 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 120d
Cleared Jun 27, 1997
LATEX EXAMINATION GLOVES, POWDER FREE
K970977 · LYY
Arista Medi Prima
General Hospital · 105d
Cleared Jun 27, 1997
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · KHO
Tosoh Medics, Inc.
Chemistry · 93d
Cleared Jun 27, 1997
ENCORE BOND
K971121 · KLE
Centrix, Inc.
Dental · 92d
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