FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79249–79272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2001
DCM 1.0
K011246 · MUJ
Mds Nordion
Radiology · 30d
Cleared May 23, 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · DQK
Cambridge Heart, Inc.
Cardiovascular · 22d
Cleared May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457 · IYN
Aloka Co., Ltd.
Radiology · 12d
Cleared May 22, 2001
BIOSPHERE MEDICAL INFUSION CATHETER
K003105 · DQO
Biosphere Medical
Cardiovascular · 230d
Cleared May 22, 2001
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
K003318 · GEX
Paradigm Medical Industries, Inc.
General & Plastic Surgery · 210d
Cleared May 22, 2001
CONCENTRIC RETRIEVER, MODEL 90030
K003410 · DQY
Concentric Medical, Inc.
Cardiovascular · 201d
Cleared May 22, 2001
VHF ULTRASONIC ARC-SCAN SYSTEM
K003890 · IYO
Ultralink, LLC
Radiology · 155d
Cleared May 22, 2001
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918 · DTB
Oscor, Inc.
Cardiovascular · 154d
Cleared May 22, 2001
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES...
K003978 · NEY
Afx, Inc.
General & Plastic Surgery · 151d
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