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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101545–101568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1995
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
K953510 · KWY
Encore Orthopedics, Inc.
Orthopedic · 14d
Cleared Aug 08, 1995
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
K945229 · DRF
Arrow Intl., Inc.
Cardiovascular · 286d
Cleared Aug 08, 1995
GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM
K946088 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 238d
Cleared Aug 08, 1995
TRANSIT-2 INFUSION CATHETER
K950910 · DQO
Cordis Neurovascular, Inc.
Cardiovascular · 176d
Cleared Aug 08, 1995
BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER
K951273 · FLE
Buxton Medical Servic Corp.
General Hospital · 140d
Cleared Aug 08, 1995
AXSYM SALICYLATE
K951290 · DKJ
Abbott Laboratories
Toxicology · 140d
Cleared Aug 08, 1995
TRUEFILL PVA PARTICLES
K951314 · HCG
Cordis Neurovascular, Inc.
Neurology · 138d
Cleared Aug 08, 1995
RUSCH ENDOTRACHEAL TUBE STYLET
K952100 · BSR
Rusch, Inc.
Anesthesiology · 96d
Cleared Aug 08, 1995
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
K952568 · LCR
Beckman Instruments, Inc.
Toxicology · 64d
Cleared Aug 08, 1995
HENNERT SA
K952734 · HQY
Hennert S.A.
Ophthalmic · 54d
Cleared Aug 08, 1995
STRYKER COMMAND2 OFFICE CONSOLE
K953071 · JEA
Stryker Instruments
General & Plastic Surgery · 39d
Cleared Aug 08, 1995
STELKAST ALL POLYETHYLENE ACETABULAR CUP
K953169 · LZO
Stelkast Company
Orthopedic · 32d
Cleared Aug 08, 1995
PULM O2 SUCTION CATHETER TRAYS
K953226 · BSY
Premium Plastics, Inc.
Anesthesiology · 33d
Cleared Aug 07, 1995
CRADLE FIXATION DEVICE
K941772 · JDR
Neoligaments, Ltd.
Orthopedic · 483d
Cleared Aug 07, 1995
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
K942200 · LYU
Thantex Specialties, Inc.
General Hospital · 459d
Cleared Aug 07, 1995
MICRO ICS SONIC SCALER
K942380 · ELC
Micro Motors, Inc.
Dental · 445d
Cleared Aug 07, 1995
ZEROID HEMORRHOIDAL DEVICE
K944874 · LKX
Medical Appliance Research Corp.
Gastroenterology & Urology · 308d
Cleared Aug 07, 1995
PERSONAL ALARM SYSTEM (PAS)
K944961 · LDQ
Cytoprobe Corp.
General & Plastic Surgery · 304d
Cleared Aug 07, 1995
HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES
K945766 · LYY
Ansell, Inc.
General Hospital · 259d
Cleared Aug 07, 1995
SIEMENS SONOLINE VERSA
K945773 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 255d
Cleared Aug 07, 1995
HOMEVUE WOUND MONITORING SYSTEM
K945807 · LLZ
Homevue Health Systems, Inc.
Radiology · 252d
Cleared Aug 07, 1995
COATEST(R) APC(TM) RESISTANCE
K945940 · GGW
Axis-Shield Doc AS
Hematology · 245d
Cleared Aug 07, 1995
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K946348 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Aug 07, 1995
PHOTODERM VL.
K950493 · GEX
Esc, Energy Systems Corp.
General & Plastic Surgery · 182d