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
130441–130464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1989
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
K892227 · DSH
Edentec Corp.
Cardiovascular · 77d
Cleared Jun 20, 1989
ENZYMATIC UREA NITROGEN REAGENT SET
K892331 · CDQ
American Monitor Corp.
Chemistry · 76d
Cleared Jun 20, 1989
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
K892818 · CFE
Helena Laboratories
Chemistry · 64d
Cleared Jun 20, 1989
AST REAGENT (PROCEDURE NUMBER 158)
K892844 · CIT
Sigma Chemical Co.
Chemistry · 63d
Cleared Jun 20, 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224 · LCP
Helena Laboratories
Hematology · 54d
Cleared Jun 20, 1989
INTRA AORTIC BALLOON
K893243 · DSP
Datascope Corp.
Cardiovascular · 19d
Cleared Jun 20, 1989
L30-LB- INFANT LIMB BAND
K893245 · DRX
Contour Electrodes, Inc.
Cardiovascular · 53d
Cleared Jun 20, 1989
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392 · DXG
Baxter Healthcare Corp
Cardiovascular · 50d
Cleared Jun 20, 1989
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
K893423 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 49d
Cleared Jun 20, 1989
ARGENCO 60 TYPE IV DENTAL GOLD ALLOY
K893554 · EJT
Argen Precious Metals, Inc.
Dental · 43d
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