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
74881–74904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2002
SYNTHES 3.5 MM BROAD LC-DCP PLATES
K020872 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jun 12, 2002
ULTRA-LITE 5 TURBO LIGHT CURE UNIT
K020874 · EBZ
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
EXCELLITE TURBO LIGHT CURE UNIT
K020877 · EBZ
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
EXCELLITE LIGHT CURE UNIT
K020884 · EBZ
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
ESOP CO-CR FEMORAL HEADS
K021109 · LPH
Fournitures Hospitalieres
Orthopedic · 68d
Cleared Jun 12, 2002
DERMMATRIX SURGICAL MESH
K021160 · FTM
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 62d
Cleared Jun 12, 2002
HNC-127-TRIO NEUROVASCULAR ARRAY COIL
K021570 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 12, 2002
OBC-127 BREAST ARRAY COIL
K021575 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Jun 12, 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · LOD
Exactech, Inc.
Orthopedic · 20d
Cleared Jun 12, 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · GZJ
Apex Medical Corp.
Neurology · 14d
Cleared Jun 11, 2002
SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
K012512 · NCX
Radiant Medical
Neurology · 309d
Cleared Jun 11, 2002
PLEXOLONG SETS
K013041 · CAZ
Pajunk GmbH
Anesthesiology · 274d
Cleared Jun 11, 2002
BIOSCREW XTRALOK
K013131 · HWC
Linvatec Corp.
Orthopedic · 265d
Cleared Jun 11, 2002
CALCIGEN-S BONE VOID FILER
K013790 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 209d
Cleared Jun 11, 2002
OXYARM CO2
K014211 · CCK
Southmedic, Inc.
Anesthesiology · 172d
Cleared Jun 11, 2002
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64...
K020410 · LON
Dade Behring, Inc.
Microbiology · 124d
Cleared Jun 11, 2002
RABEA CEMENT RESTRICTOR
K020836 · JDK
Signus Medical, LLC
Orthopedic · 89d
Cleared Jun 11, 2002
FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM
K020866 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 85d
Cleared Jun 11, 2002
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
K020869 · DKZ
Worldwide Medical Corp.
Toxicology · 85d
Cleared Jun 11, 2002
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
K021018 · JWY
Dade Microscan, Inc.
Microbiology · 74d
Cleared Jun 11, 2002
COULTER CELLPREP
K021150 · GKH
Beckman Coulter, Inc.
Hematology · 62d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · NBW
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jun 11, 2002
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH...
K021561 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 29d
Cleared Jun 11, 2002
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K021667 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 21d