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
74545–74568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2002
POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN...
K022442 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 42d
Cleared Sep 05, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
K022502 · KZE
Equidyne Systems, Inc.
General Hospital · 38d
Cleared Sep 05, 2002
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
K022647 · HWC
Triad Medical, Inc.
Orthopedic · 27d
Cleared Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Sep 05, 2002
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
K022766 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 15d
Cleared Sep 04, 2002
QUINTON Q-CATH, MODEL 000460
K021906 · DQK
Quinton, Inc.
Cardiovascular · 86d
Cleared Sep 04, 2002
IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K021907 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 86d
Cleared Sep 04, 2002
HRW-63-INT WRIST ARRAY COIL
K022588 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621 · DQO
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 03, 2002
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL...
K002612 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 743d
Cleared Sep 03, 2002
EYEFEEL OPHTHALMIC WARMER
K021843 · IMD
Bio-Lipid, Inc.
Physical Medicine · 90d
Cleared Sep 03, 2002
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
K021847 · FCG
Biopsy Sciences, LLC
Gastroenterology & Urology · 90d
Cleared Sep 03, 2002
CLARUS STRAIGHT FIRING LASER FIBER
K021848 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 90d
Cleared Sep 03, 2002
LUCIUS 62
K021948 · EJT
Lucius Metals Com.
Dental · 82d
Cleared Sep 03, 2002
SYNTHES MIDFACE DISTRACTOR
K022005 · JEY
Synthes (Usa)
Dental · 76d
Cleared Sep 03, 2002
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
K022042 · DWF
Cardeon Corp.
Cardiovascular · 71d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
K022088 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
K022090 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K022092 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 68d
Cleared Sep 03, 2002
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
K022146 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 63d
Cleared Sep 03, 2002
RAICHEM LIPID CALIBRATOR
K022767 · JIX
Hemagen Diagnostics, Inc.
Chemistry · 13d
Cleared Aug 30, 2002
SLEEPFLO, MODEL 101501
K020607 · MNR
Biomec, Inc.
Anesthesiology · 186d
Cleared Aug 30, 2002
VERACAM
K021083 · EIA
Lumalite, Inc.
Dental · 149d
Cleared Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU,...
K021162 · JPA
Sigma Diagnostics, Inc.
Hematology · 141d