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
131041–131064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1989
ARGENCO 42 TYPE IV DENTAL GOLD ALLOY
K893563 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Jun 20, 1989
ARGENCO 30 TYPE IV DENTAL GOLD ALLOY
K893564 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Jun 20, 1989
ARGENCO 52 TYPE IV DENTAL GOLD ALLOY
K893567 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Jun 20, 1989
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
K893605 · CEP
Serono-Baker Diagnostics, Inc.
Chemistry · 41d
Cleared Jun 20, 1989
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633 · DTE
Medtronic Vascular
Cardiovascular · 40d
Cleared Jun 19, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891374 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 102d
Cleared Jun 19, 1989
SAMBORD LATEX PATIENT EXAMINATION GLOVES
K891644 · LYY
Polymint Industrial Co. , Ltd.
General Hospital · 94d
Cleared Jun 19, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891702 · LYY
Thai Nam Rubber Gloves Co., Ltd.
General Hospital · 91d
Cleared Jun 19, 1989
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
K891912 · CDQ
American Research Products Co.
Chemistry · 84d
Cleared Jun 19, 1989
THE ROYAL GLOVES (PATIENT EXAM GLOVES)
K891958 · LYY
Taizhu Latex Glove Factory , Ltd.
General Hospital · 82d
Cleared Jun 19, 1989
PATIENT EXAMIAINATION GLOVES (LATEX)
K892247 · LYY
Jiann FA Rubber Factory Co., Ltd.
General Hospital · 75d
Cleared Jun 19, 1989
QUALITEX LATEX EXAMINATION GLOVES
K892414 · LYY
Agri-Bag Corp.
General Hospital · 67d
Cleared Jun 19, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892471 · LYY
Tabri Gloves Sdn. Bhd.
General Hospital · 73d
Cleared Jun 19, 1989
BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST
K892654 · DHA
Princeton Biomedix
Chemistry · 67d
Cleared Jun 19, 1989
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
K892905 · CIG
Catachem, Inc.
Chemistry · 60d
Cleared Jun 19, 1989
LOW POWDER SINGLE USE LATEX EXAM GLOVES
K892975 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 68d
Cleared Jun 19, 1989
LATEX EXAMINATION GLOVES
K893015 · LYY
Universal Gloves Private , Ltd.
General Hospital · 68d
Cleared Jun 19, 1989
CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES
K893107 · LYY
Winmed Instruments Mfg. Corp.
General Hospital · 66d
Cleared Jun 19, 1989
WARDEN LATEX EXAMINATION GLOVES
K893179 · LYY
Kuo Jun Ent. Co., Ltd.
General Hospital · 48d
Cleared Jun 19, 1989
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
K893211 · CEF
Helena Laboratories
Chemistry · 53d
Cleared Jun 19, 1989
LATEX EXAMINATION GLOVES
K893268 · LYY
Regulus Intl. Corp.
General Hospital · 63d
Cleared Jun 19, 1989
CHOLESTEROL REAGENT SET
K893479 · CHH
American Monitor Corp.
Chemistry · 46d
Cleared Jun 16, 1989
AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL
K881196 · IPF
Biometer Intl. A/S
Physical Medicine · 452d
Cleared Jun 16, 1989
OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
K884884 · ETA
Porex Technologies Corp. of Georgia
Ear, Nose, Throat · 206d