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
71281–71304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2003
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
K031606 · LFX
Beckman Coulter, Inc.
Microbiology · 29d
Cleared Jun 20, 2003
DATEX-OHMEDA HMEF 750
K031653 · CAH
Datex-Ohmeda
General Hospital · 23d
Cleared Jun 20, 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 21d
Cleared Jun 20, 2003
C.CAM
K031825 · KPS
Danish Diagnostic Development A/S
Radiology · 7d
Cleared Jun 20, 2003
AUTOBONE
K031871 · JAK
Ge Medical Systems Europe
Radiology · 3d
Cleared Jun 20, 2003
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
K031872 · KPS
Adac Laboratories
Radiology · 3d
Cleared Jun 19, 2003
CARE ETS
K023036 · IPF
Care Rehab and Orthopaedic
Physical Medicine · 280d
Cleared Jun 19, 2003
C-1805M
K023815 · EIA
Anodia Systems
Dental · 216d
Cleared Jun 19, 2003
C-1890
K023896 · EIA
Anodia Systems
Dental · 209d
Cleared Jun 19, 2003
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL...
K024093 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 190d
Cleared Jun 19, 2003
CP MEDICAL BONE WAX
K024372 · MTJ
Cp Medical
General & Plastic Surgery · 170d
Cleared Jun 19, 2003
GENICON LAPAROSCOPES
K030174 · GCJ
Genicon, LC
General & Plastic Surgery · 153d
Cleared Jun 19, 2003
DISPOSABLE M2-PE MICROKERATOME BLADES
K030401 · HNO
Oasis Medical, Inc.
Ophthalmic · 133d
Cleared Jun 19, 2003
SKINSTATION
K030897 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 90d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · HWC
Inion , Ltd.
Orthopedic · 87d
Cleared Jun 19, 2003
UFI GEL HARD C
K030916 · EBI
Voco GmbH
Dental · 87d
Cleared Jun 19, 2003
HEMCON BANDAGE OTC
K030946 · QSY
Hemcon, Inc.
General & Plastic Surgery · 85d
Cleared Jun 19, 2003
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K031029 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 79d
Cleared Jun 19, 2003
FLUENCY TRACHEOBRONCHIAL STENT GRAFT
K031041 · JCT
Bard Peripheral Vascular
General & Plastic Surgery · 79d
Cleared Jun 19, 2003
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164 · DTD
Oscor, Inc.
Cardiovascular · 66d
Cleared Jun 19, 2003
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
K031177 · MSV
Axis-Shield Diagnostics, Ltd.
Immunology · 66d
Cleared Jun 19, 2003
SOLUTION FACE MASKS
K031353 · FXX
A Plus International, Inc.
General Hospital · 51d
Cleared Jun 19, 2003
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
K031571 · IZQ
E-Z-Em, Inc.
Radiology · 30d
Cleared Jun 19, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K031626 · LJS
AngioDynamics, Inc.
General Hospital · 23d