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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129049–129072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1989
ADG BONE BIOPSY SYSTEM
K890722 · GDM
American Design Group, Inc.
General & Plastic Surgery · 220d
Cleared Sep 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891429 · LYY
Wei Ming Industry Co. , Ltd.
General Hospital · 191d
Cleared Sep 21, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892077 · LYY
Forchic Corp. of USA
General Hospital · 171d
Cleared Sep 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892556 · LYY
Fabella Industries Sdn Bhd
General Hospital · 164d
Cleared Sep 21, 1989
IFA SENSIBAC NORFLOXACIN
K892728 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 160d
Cleared Sep 21, 1989
ANTELOPE BRAND PATIENT EXAMINATION GLOVES
K892781 · LYY
Liaoning-Usa Corp.
General Hospital · 163d
Cleared Sep 21, 1989
PATIENT EXAMINATION GLOVES
K892921 · LYY
Millimax Corp.
General Hospital · 162d
Cleared Sep 21, 1989
GLOBE PATIENT EXAMINATION GLOVES
K893000 · LYY
Lucky and Happy, Inc.
General Hospital · 162d
Cleared Sep 21, 1989
VISTA STREAK RETINOSCOPE (AC-POWERED)
K893171 · HKL
Keeler Instruments, Inc.
Ophthalmic · 149d
Cleared Sep 21, 1989
VINYL EXAM GLOVES
K893271 · LYZ
Consul Chemical Industry Corp.
General Hospital · 157d
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