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
88105–88128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1998
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 365d
Cleared Nov 12, 1998
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K980711 · LPH
Zimmer, Inc.
Orthopedic · 261d
Cleared Nov 12, 1998
ESPRIT VENTILATOR
K981072 · CBK
Respironics, Inc.
Anesthesiology · 233d
Cleared Nov 12, 1998
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID...
K981885 · INI
Sunrise Medical, Inc.
Physical Medicine · 167d
Cleared Nov 12, 1998
PROFA
K981911 · IYE
Duncan Hynd Associates, Ltd.
Radiology · 164d
Cleared Nov 12, 1998
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
K982831 · JXM
OraSure Technologies, Inc.
Toxicology · 93d
Cleared Nov 12, 1998
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
K982906 · MQN
Walter Lorenz Surgical, Inc.
Dental · 86d
Cleared Nov 12, 1998
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · DGC
Boehringer Mannheim Corp.
Immunology · 62d
Cleared Nov 12, 1998
DIGOXIN IMMUNOASSAY
K983323 · KXT
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Nov 12, 1998
STARRYSHINE GAUZE SPONGE
K983450 · EFQ
T.C. Dental Products, Inc.
General & Plastic Surgery · 43d
Cleared Nov 12, 1998
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · JPA
American Bioproducts Co.
Hematology · 43d
Cleared Nov 12, 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K983517 · JKA
Ram Scientific
Chemistry · 36d
Cleared Nov 12, 1998
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
K983578 · JJX
Bio-Rad
Chemistry · 30d
Cleared Nov 12, 1998
CV PERI-GUARD AND VASCU-GUARD
K983602 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 30d
Cleared Nov 12, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K983706 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 22d
Cleared Nov 12, 1998
STRATEGY CORONARY WIRE GUIDE
K983771 · DQX
Cook, Inc.
Cardiovascular · 17d
Cleared Nov 10, 1998
DIAPACT CRRT
K973322 · KDI
B.Braun Medical, Inc.
Gastroenterology & Urology · 432d
Cleared Nov 10, 1998
CMS-2000
K982843 · MWJ
Industrial Technology Research Institute
Cardiovascular · 90d
Cleared Nov 10, 1998
MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
K982854 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 89d
Cleared Nov 10, 1998
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
K982876 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Nov 10, 1998
PERIPHERAL NERVE STIMULATION
K982902 · GZF
Medtronic Vascular
Neurology · 88d
Cleared Nov 10, 1998
DIGITAL ECG HOLTER RECORDER, MODEL DR512
K982975 · MWJ
Datrix
Cardiovascular · 76d
Cleared Nov 10, 1998
ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE
K983033 · DQX
Guidant Corp.
Cardiovascular · 71d
Cleared Nov 10, 1998
RESPIRATORY HUMIDIFIER, MODEL # MR850
K983112 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 67d