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
91849–91872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970654 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Nov 12, 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
K970661 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Nov 12, 1997
BCI MODEL 6004 NIBP MONITOR (6004)
K970801 · DXN
Bci Intl., Inc.
Cardiovascular · 253d
Cleared Nov 12, 1997
CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)
K970907 · FLE
Getinge/Castle, Inc.
General Hospital · 246d
Cleared Nov 12, 1997
MIE FALCON, DATEX ENGSTROM FLEXIMA II
K971030 · BSZ
Medical and Industrial Equipment
Anesthesiology · 237d
Cleared Nov 12, 1997
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
K971803 · MNR
Neurotronics, Inc.
Anesthesiology · 184d
Cleared Nov 12, 1997
ODI COMPRESSION HIP SCREW SYSTEM
K971993 · KTT
Orthopaedic Designs, Inc.
Orthopedic · 167d
Cleared Nov 12, 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596 · LPH
Depuy, Inc.
Orthopedic · 124d
Cleared Nov 12, 1997
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID...
K973036 · MGP
3M Healthcare
General & Plastic Surgery · 90d
Cleared Nov 12, 1997
ADJUSTABLE THERASNORE
K973038 · LRK
Distar, Inc.
Dental · 90d
Cleared Nov 12, 1997
BONE GRAFT SCREW SYSTEM
K973056 · DZL
Bicon, Inc.
Dental · 89d
Cleared Nov 12, 1997
1.4 FR MAPCATH SENSOR STYLET
K973057 · LJS
Navion Biomedical Corp.
General Hospital · 89d
Cleared Nov 12, 1997
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)
K973131 · LMD
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Nov 12, 1997
HEART ACCESS PLUS CARDIAC EVENT RECORDER
K973141 · DXH
Paceart, Inc.
Cardiovascular · 83d
Cleared Nov 12, 1997
BONE GRAFT HARVESTER
K973560 · HWE
Ds Mfg., Inc.
Orthopedic · 54d
Cleared Nov 12, 1997
ACE VALPROIC ACID REAGENT, AED CALIBRATORS
K973581 · LEG
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ACE PRIMIDONE REAGENT, AED CALIBRATORS
K973582 · DJD
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
K973583 · KLS
Schiapparelli Biosystems, Inc.
Toxicology · 51d
Cleared Nov 12, 1997
ELECSYS FOLATE
K973674 · CDD
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Nov 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
K973850 · HFO
Alexander Mfg. Co.
Obstetrics & Gynecology · 35d
Cleared Nov 10, 1997
IMX CA 15-3
K964407 · MOI
Abbott Laboratories
Immunology · 371d
Cleared Nov 10, 1997
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · MAI
United States Surgical, A Division of...
Orthopedic · 314d
Cleared Nov 10, 1997
APO-TEK LP(A)
K970302 · DFC
Perimmune, Inc.
Immunology · 287d
Cleared Nov 10, 1997
RAVEN DRY PRINTER
K972660 · LMC
Sterling Diagnostic Imaging, Inc.
Radiology · 117d