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
129961–129984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1989
CASS SYSTEM
K894263 · HAW
Medical Instrumentation & Diagnostics...
Neurology · 73d
Cleared Sep 01, 1989
CT HILIGHT ADVANTAGE
K894269 · JAK
GE Medical Systems
Radiology · 71d
Cleared Sep 01, 1989
FPR TOBRAMYCIN KIT
K894531 · LFW
Colony Laboratories, Inc.
Toxicology · 43d
Cleared Sep 01, 1989
FPR TOBRAMYCIN CALIBRATOR KIT
K894532 · DLJ
Colony Laboratories, Inc.
Toxicology · 43d
Cleared Aug 31, 1989
DISPOSABLE NON STERILE LATEX EXAM GLOVES
K890905 · LYY
Harvest Intl. of America, Inc.
General Hospital · 185d
Cleared Aug 31, 1989
LI WAH LATEX EXAMINATION GLOVES
K891323 · LYY
Li Wah-Hong Kong, Inc.
General Hospital · 171d
Cleared Aug 31, 1989
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
K891674 · CCL
Preemicare Corp.
Anesthesiology · 163d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891724 · LYY
United Lion Rubber Industries Sdn. Bhd.
General Hospital · 163d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891730 · LYY
Athena Mfg., Inc.
General Hospital · 162d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891731 · LYY
Southern Medical Products, Inc.
General Hospital · 162d
Cleared Aug 31, 1989
BION EBV-G (VCA) TEST SYSTEM
K891785 · JRY
Bion Ent., Ltd.
Microbiology · 160d
Cleared Aug 31, 1989
MICROMED LATEX EXAMINATION GLOVES
K891793 · LYY
Siamland, Inc.
General Hospital · 161d
Cleared Aug 31, 1989
SOFCARE PATIENT EXAMINATION GLOVES (LATEX)
K891965 · LYY
P. T. Tata Rubberindo Industries
General Hospital · 155d
Cleared Aug 31, 1989
BIOCHEM 8100 ANESTHETIC AGENT MONITOR
K892646 · CBQ
Biochem International, Inc.
Anesthesiology · 141d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES
K892963 · LYY
Mao Gang Industrial Co.
General Hospital · 141d
Cleared Aug 31, 1989
LATEX NON-STERILE PATIENT EXAMINATION GLOVES
K892973 · LYY
Polikon Trading Co.
General Hospital · 141d
Cleared Aug 31, 1989
LATEX EXAMINATION GLOVES
K893450 · LYY
Ken FA Latex Products Corp.
General Hospital · 120d
Cleared Aug 31, 1989
EMDS CREATINE KINASE ITEM NIMBER 65411
K893691 · CGS
Diagnostic Systems
Chemistry · 107d
Cleared Aug 31, 1989
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
K893838 · JQP
Ciba Corning Diagnostics Corp.
Chemistry · 99d
Cleared Aug 31, 1989
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K894022 · LYY
Baxter Healthcare Corp
General Hospital · 86d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K894023 · LYZ
Baxter Healthcare Corp
General Hospital · 86d
Cleared Aug 31, 1989
EVAC-TUBE
K894032 · CAO
Sharn, Inc.
Anesthesiology · 86d
Cleared Aug 31, 1989
QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
K894057 · LBS
Photec Diagnostics, Inc.
Chemistry · 85d