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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
169945–169968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 347-01
K790099 · DXY
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 348-01
K790100 · DXY
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 24, 1979
ISOLATION SLEEVE, MODEL 346-01
K790101 · DXY
Intermedics, Inc.
Cardiovascular · 8d
Cleared Jan 23, 1979
PUMP, BALLOON MODEL 10
K781848 · DSP
Avco Medical Products
Cardiovascular · 92d
Cleared Jan 23, 1979
TREMOR MONITOR
K782036 · GYD
Columbus Instruments Intl. Corp.
Neurology · 49d
Cleared Jan 23, 1979
STOPCOCKS, MANIFOLDS
K782095 · DTL
Namic
Cardiovascular · 36d
Cleared Jan 22, 1979
SILASTIC NEPHROSTOMY SYSTEM
K781664 · GBO
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 116d
Cleared Jan 22, 1979
RESPIRATOR/GILL 1/SIMV
K781706 · CBO
Chemetron Medical Products, Inc.
Anesthesiology · 104d
Cleared Jan 22, 1979
CATHETER, AKRON FOLEY TEFLON
K781751 · KOD
Latex Ind., Inc.
Gastroenterology & Urology · 98d
Cleared Jan 22, 1979
LASER SYSTEM, SHARPLAN 791/HE, CO2
K782030 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 48d
Cleared Jan 22, 1979
HEARING AID, MODEL GB
K782121 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jan 22, 1979
HEARING AID, MODEL AA
K782122 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jan 22, 1979
PRESSURE ALARM
K782174 · CAP
Thompson Respiration Products, Inc.
Anesthesiology · 34d
Cleared Jan 22, 1979
ICE PACK, REUSABLE FLEXIBLE
K790009 · IME
Ackrad Laboratories
Physical Medicine · 20d
Cleared Jan 18, 1979
MONITOR, OXYCHEK OXYGEN
K782114 · CCL
Critikon Company, LLC
Anesthesiology · 29d
Cleared Jan 17, 1979
LIDOCAINE CALIBRATOR KIT
K780731 · DLJ
Vitek Systems, Inc.
Toxicology · 260d
Cleared Jan 17, 1979
CORDIA R
K780885 · GOL
Cordis Corp.
Microbiology · 236d
Cleared Jan 17, 1979
MIRROR WARMER
K781750 · KAI
Arleton Technical Products, Inc.
Ear, Nose, Throat · 93d
Cleared Jan 17, 1979
FILTER, EYRPUR DISPOSABLE LEUKOCITE
K781803 · GKT
Metrix Teknika, Inc.
Hematology · 86d
Cleared Jan 17, 1979
REAGENT SYSTEM, INORGANIC PHOSPHORUS
K781806 · CEO
Sigma Chemical Co.
Chemistry · 84d
Cleared Jan 17, 1979
SOLUTION ADMINISTRATION, TIP PROTECTOR
K781813 · FPA
Travenol Laboratories, S.A.
General Hospital · 83d
Cleared Jan 17, 1979
DIALYSATE DELIVERY SYSTEM
K781886 · FKP
Cordis Corp.
Gastroenterology & Urology · 71d
Cleared Jan 17, 1979
PROTHESIS, METACARPAL
K781937
Cutter Laboratories, Inc.
Orthopedic · 58d
Cleared Jan 17, 1979
GLUCOSE OXIDASE REAGENT
K781945 · CGA
Fermco Biochemics, Inc.
Chemistry · 57d