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
129361–129384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892072 · LYY
Gaw Rubber Products Sdn. Bhd.
General Hospital · 151d
Cleared Sep 01, 1989
CHAMP-PAQ VINYL PATIENT EXAM GLOVES
K892079 · LYZ
Winmed Instruments Mfg. Corp.
General Hospital · 151d
Cleared Sep 01, 1989
SHIH KUO LATEX EXAM GLOVE
K892083 · LYY
Beverly Ent., Inc.
General Hospital · 151d
Cleared Sep 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892084 · LYY
Mirano Sdn. Bhd.
General Hospital · 151d
Cleared Sep 01, 1989
PATIENT EXAM GLOVES (MFG. SHANGHAI LATEX FACTORY)
K892181 · LYY
Grand Monde Trading Co., Inc.
General Hospital · 149d
Cleared Sep 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892485 · LYY
Intl. Pacific Industrial Corp. (Usa),...
General Hospital · 147d
Cleared Sep 01, 1989
LATEX EXAMINATION GLOVES
K893591 · LYY
Shanghai Medicines & Health Products...
General Hospital · 115d
Cleared Sep 01, 1989
PATIENT EXAMINATION GLOVES
K893595 · LYY
Arcofield , Ltd.
General Hospital · 115d
Cleared Sep 01, 1989
MEDISYS RECORD AND VERIFY SYSTEM
K893978 · IYE
Medisys, Inc.
Radiology · 91d
Cleared Sep 01, 1989
MOBILE X-RAY UNIT
K894021 · IZL
Ziehm International, Inc.
Radiology · 87d
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