FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129649–129672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1989
LATEX EXAMINATION GLOVES
K893882 · LYY
Sinochem (Usa), Inc.
General Hospital · 118d
Cleared Sep 21, 1989
CUSIS ULTRASOUND SKIN IMAGING SYSTEM
K893996 · IYO
Stiefel Research Institute, Inc.
Radiology · 108d
Cleared Sep 21, 1989
RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE
K894019 · KHL
Resound Corp.
Ear, Nose, Throat · 107d
Cleared Sep 21, 1989
LATEX EXAMINATION GLOVES
K894080 · LYY
Shanghai Intl. Corp.
General Hospital · 105d
Cleared Sep 21, 1989
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
K894103 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 104d
Cleared Sep 21, 1989
PATIENT EXAM GLOVES (MFG: GLOVES INT'L LTD.)
K894178 · LYY
Lanka Products, Inc.
General Hospital · 98d
Cleared Sep 21, 1989
PATIENT EXAMINATION GLOVES
K894196 · LYY
Lanka Products, Inc.
General Hospital · 99d
Cleared Sep 21, 1989
PATIENT EXAMINATION GLOVES
K894375 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Sep 21, 1989
LATEX EXAMINATION GLOVES
K894386 · LYY
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 66d
Cleared Sep 21, 1989
ARMOR, LATEX EXAMINATION GLOVES
K894499 · LYY
Prestige Manufacturing Snd Bhd
General Hospital · 64d
Cleared Sep 21, 1989
ANA ANTISERA CONTROL KIT
K894659 · DHN
Lipogen, Inc.
Immunology · 59d
Cleared Sep 21, 1989
LATEX PATIENT EXAMINATION GLOVES
K894696 · LYY
Sun Holy Manufactory , Ltd.
General Hospital · 59d
Cleared Sep 21, 1989
LASERMED* GOGGLES AND SPECTACLES
K894835 · HQF
Glendale Protective Technologies, Inc.
Ophthalmic · 52d
Cleared Sep 21, 1989
PROGENE IGE BEAD EIA
K895294 · DGC
Progene Corp.
Immunology · 27d
Cleared Sep 21, 1989
MULTIPLE MENTAL SPECTACLE FRAMES
K895300 · HQZ
Optica Trade S.A.
Ophthalmic · 27d
Cleared Sep 21, 1989
FLEX EYEWEAR FRAMES
K895371 · HQZ
Flex Eyewear, Inc.
Ophthalmic · 23d
Cleared Sep 21, 1989
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · DDB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 22d
Cleared Sep 20, 1989
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892797 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892798 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892799 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · DSY
Medtronic Vascular
Cardiovascular · 140d
Cleared Sep 20, 1989
OPUS MODELS 4033 AND 4034
K894267 · DXY
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Sep 20, 1989
MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE
K894981 · DSA
Medtronic Vascular
Cardiovascular · 43d
Cleared Sep 19, 1989
MEDI-TRACE ACCU-NATE DEVICE
K891193 · FPA
Graphic Controls Corp.
General Hospital · 197d