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
98617–98640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
K960120 · JFP
Nova Biomedical Corp.
Chemistry · 60d
Cleared Mar 11, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960220 · JWY
Sensititre , Ltd.
Microbiology · 55d
Cleared Mar 11, 1996
PALLIKARIS BRUSH
K960261 · HOG
Alcon Laboratories, Inc.
Ophthalmic · 53d
Cleared Mar 11, 1996
SIREGRAPH CF
K960266 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Mar 11, 1996
DISPOSABLE PATIENT RETURN ELECTRODE
K960569 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 34d
Cleared Mar 11, 1996
KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
K960791 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 11, 1996
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793 · KHS
Synermed, Inc.
Chemistry · 13d
Cleared Mar 08, 1996
TI-6AL-7NB URTN
K932330 · HSB
Synthes (Usa)
Orthopedic · 1030d
Cleared Mar 08, 1996
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K945518 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 485d
Cleared Mar 08, 1996
TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
K953607 · JDO
Synthes (Usa)
Orthopedic · 219d
Cleared Mar 08, 1996
VOLAR DISTAL RADIUS PLATE
K953644 · HRS
Synthes (Usa)
Orthopedic · 217d
Cleared Mar 08, 1996
SYNTHES WIRE MOUNT
K953777 · JDQ
Synthes (Usa)
Orthopedic · 207d
Cleared Mar 08, 1996
SYNTHES (USA) MIDFACIAL SYSTEM
K953806 · JEY
Synthes (Usa)
Dental · 211d
Cleared Mar 08, 1996
SERIES 50XM
K954351 · HGM
Hewlett-Packard GmbH
Obstetrics & Gynecology · 172d
Cleared Mar 08, 1996
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · JEY
Synthes (Usa)
Dental · 171d
Cleared Mar 08, 1996
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 168d
Cleared Mar 08, 1996
CANNULATED FEMORAL NAIL
K954856 · JDN
Synthes (Usa)
Orthopedic · 137d
Cleared Mar 08, 1996
IONOSIT SEAL
K954867 · EBC
Foremost Dental Mfg., Inc.
Dental · 136d
Cleared Mar 08, 1996
CRYSTALLESSENCE
K954988 · EBF
Confi-Dental Products Co.
Dental · 129d
Cleared Mar 08, 1996
MODEL 1100 COLD THERAPY DEVICE
K955057 · ILO
Smith and Nephew Donjoy, Inc.
Physical Medicine · 123d
Cleared Mar 08, 1996
VITAL PAK
K955417 · DXG
Vital Signs, Inc.
Cardiovascular · 102d
Cleared Mar 08, 1996
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K955619 · DZE
Calcitek, Inc.
Dental · 88d
Cleared Mar 08, 1996
NIGHTGUARD DIAGNOSTIC APPLIANCE
K955701 · MQC
Cycura Corp.
Dental · 84d
Cleared Mar 08, 1996
NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
K955778 · HRY
Intermedics Orthopedics
Orthopedic · 79d