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
92905–92928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1997
CHASE PHRENIC NERVE PAD
K971021 · DWF
Chase Medical, Inc.
Cardiovascular · 145d
Cleared Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
K971152 · GKZ
Abbott Laboratories
Hematology · 137d
Cleared Aug 12, 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657 · JJY
Boston Biomedica, Inc.
Microbiology · 98d
Cleared Aug 12, 1997
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
K971796 · EZL
Louisville Laboratories, Inc.
Orthopedic · 89d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
K971827 · DQA
Alexander Mfg. Co.
Anesthesiology · 88d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
K971828 · DQA
Alexander Mfg. Co.
Anesthesiology · 88d
Cleared Aug 12, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 84d
Cleared Aug 12, 1997
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING...
K971881 · FJL
Comeg Endoscopy
Gastroenterology & Urology · 84d
Cleared Aug 12, 1997
AMERIGEL OINTMENT SATURATED WOUND DRESSING
K971918 · MGQ
Amerx Health Care Corp.
General & Plastic Surgery · 81d
Cleared Aug 12, 1997
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
K971977 · FBN
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Aug 12, 1997
KARL STORZ MODEL 203020 20 EQUIMAT
K971982 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Aug 12, 1997
VISUALINE II METHAMPHETIMINE
K972032 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 71d
Cleared Aug 12, 1997
ACCURUN 117 HBEAG POSITIVE CONTROL
K972048 · JJY
Boston Biomedica, Inc.
Microbiology · 71d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K972086 · BZK
Alexander Mfg. Co.
Anesthesiology · 69d
Cleared Aug 12, 1997
ALTA INTRAMEDULLARY ROD SYSTEM
K972108 · HSB
Howmedica Corp.
Orthopedic · 68d
Cleared Aug 12, 1997
CHLAMYDIATROL AG
K972129 · MJZ
Blackhawk Biosystems, Inc.
Microbiology · 67d
Cleared Aug 12, 1997
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · KFF
Medical Diagnostic Technologies, Inc.
Hematology · 62d
Cleared Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
K972235 · JJY
Boehringer Mannheim Corp.
Immunology · 57d
Cleared Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Aug 12, 1997
TOOL-LESS WHEEL CHAIR
K972797 · IOR
Sunrise Medical, Inc.
Physical Medicine · 15d
Cleared Aug 11, 1997
ANODYNE CC
K963481 · BSZ
Heyer America, Inc.
Anesthesiology · 342d
Cleared Aug 11, 1997
ZIP CONDOM CATHETER
K964219 · EYZ
Goulter Medical, Inc.
Gastroenterology & Urology · 293d
Cleared Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431 · LZO
Biomet, Inc.
Orthopedic · 279d
Cleared Aug 11, 1997
QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM
K964444 · HSB
Rdh Medical
Orthopedic · 278d