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
78745–78768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2001
PALOMAR SLP 1000
K010580 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 84d
Cleared May 22, 2001
ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
K010711 · KKX
Advanced Surgical Concepts (Asc)
General Hospital · 74d
Cleared May 22, 2001
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787 · DTD
Oscor, Inc.
Cardiovascular · 68d
Cleared May 21, 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
K000733 · NBT
Inova Diagnostics, Inc.
Immunology · 441d
Cleared May 21, 2001
PELVEX HOMETRAINER
K002043 · HIR
Purdue Technology Park
Gastroenterology & Urology · 320d
Cleared May 21, 2001
VACUCATH I.V. CATHETER INTRODUCTER
K003187 · FOZ
Auto/Cath Vascular Access, Inc.
General Hospital · 222d
Cleared May 21, 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · LSL
Gen-Probe, Inc.
Microbiology · 201d
Cleared May 21, 2001
SYMMETRY AORTIC CLIP SYSTEM
K003446 · NCA
St. Jude Medical Cardiovascular...
General & Plastic Surgery · 196d
Cleared May 21, 2001
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT
K003589 · HAW
Brainlab AG
Neurology · 182d
Cleared May 21, 2001
CARDIAC VIEW, MODEL 2001
K010513 · MOS
Magna-Lab, Inc.
Radiology · 89d
Cleared May 21, 2001
HARMONE-SCHWARZER EEG SYSTEM
K010728 · OLV
Stellate Systems
Neurology · 70d
Cleared May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K010834 · GEX
Laserscope
General & Plastic Surgery · 62d
Cleared May 21, 2001
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864 · KHS
Hemagen Diagnostics, Inc.
Chemistry · 60d
Cleared May 21, 2001
CDMX
K010915 · MUH
Camsight Co., Inc.
Radiology · 55d
Cleared May 21, 2001
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K010936 · OXD
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 54d
Cleared May 21, 2001
SCREW-VENT DENTAL IMPLANT SYSTEM
K011028 · DZE
Sulzer Dental, Inc.
Dental · 46d
Cleared May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · DAP
Kamiya Biomedical Co.
Hematology · 239d
Cleared May 18, 2001
VASO PRESS DVT FOOT GARMENT #VP 520
K003828 · JOW
Britt Corp., Inc.
Cardiovascular · 158d
Cleared May 18, 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021,...
K010162 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 121d
Cleared May 18, 2001
VENA TECH VENA CAVA FILTER
K010485 · DTK
Bbraun
Cardiovascular · 87d
Cleared May 18, 2001
ADVANTA SST GRAFT (>_6MM)
K010516 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
ADVANTA SST GRAFT (<6MM)
K010517 · DSY
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · FMQ
Skil-Care Corp.
General Hospital · 74d
Cleared May 18, 2001
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
K010672 · GAM
Gramsmed, LLC
General & Plastic Surgery · 73d