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
132145–132168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1989
VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.)
K891568 · LYZ
Neo-Sigma, Inc.
General Hospital · 25d
Cleared Apr 11, 1989
AMMEX LATEX EXAMINATION GLOVES
K891850 · LYY
Ammex Corp.
General Hospital · 15d
Cleared Apr 11, 1989
SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX)
K891854 · LYY
Unidus Corp.
General Hospital · 15d
Cleared Apr 11, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891860 · LYZ
Cypress Medical Products, Ltd.
General Hospital · 15d
Cleared Apr 11, 1989
RUBBER LATEX PATIENT EXAMINATION GLOVES
K891866 · LYY
Amsia Intl., Inc.
General Hospital · 15d
Cleared Apr 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891883 · LYY
China National Machinery & Equipment...
General Hospital · 14d
Cleared Apr 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891885 · LYY
Alfaseal Sdn. Bhd.
General Hospital · 14d
Cleared Apr 11, 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
K891907 · JCN
R&D Systems, Inc.
Hematology · 15d
Cleared Apr 10, 1989
CRACK-IT CANNABINOID SCREEN
K874390 · LDJ
Sakers, Inc.
Toxicology · 531d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD HERPES IGG TEST KIT
K884246 · LGC
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
K884247 · LFX
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248 · LFZ
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT
K884249 · LGD
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
HTS 220 CARDIAC MONITOR
K884524 · DSI
Life Sensing Instrument Company, Inc.
Cardiovascular · 165d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
K885290 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM
K890129 · GCX
Deknatel, Inc.
General Hospital · 88d
Cleared Apr 10, 1989
PRE-MOISTENED CLEANSING PAD
K890514 · LKB
Bausch & Lomb, Inc.
General Hospital · 68d
Cleared Apr 10, 1989
HI CHEM CALCIUM REAGENT #88808
K890584 · CJY
Hichem Diagnostics
Chemistry · 63d
Cleared Apr 10, 1989
HI-RIDER WHEELCHAIR
K890695 · IPL
Retec USA, Inc.
Physical Medicine · 59d
Cleared Apr 10, 1989
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698 · CKA
Abbott Laboratories
Chemistry · 59d
Cleared Apr 10, 1989
PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
K890707 · DWS
Dlp, Inc.
Cardiovascular · 59d
Cleared Apr 10, 1989
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
K890721 · DIE
Actio, Inc.
Toxicology · 56d