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
129769–129792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893293 · LYY
Toptech Industry Corp.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893302 · LYY
Gromax Rubber Industry Co., Ltd.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893303 · LYY
Marble King Corp.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893304 · LYY
Lakewood Ent., Ltd.
General Hospital · 148d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K893306 · LYY
Acefit Intl., Inc.
General Hospital · 148d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K893593 · LYY
Strong Will Sdn Bhd
General Hospital · 127d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K893607 · LYY
Wedana Rubber Products
General Hospital · 126d
Cleared Sep 13, 1989
PATIENT EXAMINATION GLOVES
K893618 · LYY
Tenma Co. , Ltd.
General Hospital · 126d
Cleared Sep 13, 1989
PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC
K893695 · LYY
Shanghai Industrial Investment Co. ,...
General Hospital · 120d
Cleared Sep 13, 1989
MEDI + FORM EXAM (MFG: GLOVE SEAL SDN BHD)
K893719 · LYY
World Impex Corp.
General Hospital · 119d
Cleared Sep 13, 1989
CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE
K893867 · DQA
Spacelabs, Inc.
Anesthesiology · 110d
Cleared Sep 13, 1989
LATEX EXAMINATION GLOVES
K894079 · LYY
Target USA, Inc.
General Hospital · 97d
Cleared Sep 13, 1989
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · CIT
Abbott Laboratories
Chemistry · 89d
Cleared Sep 13, 1989
REP TM SPE (PONCEAU S) PROCEDURES
K894585 · CEF
Helena Laboratories
Chemistry · 51d
Cleared Sep 13, 1989
COULTER POSITIVE CONTROL CELLS
K894651 · GGL
Coulter Corp.
Hematology · 51d
Cleared Sep 13, 1989
ELECTROTRACE DISP. RESTING EKG ELECTRODES
K894679 · DRX
Jason Marketing Co.
Cardiovascular · 50d
Cleared Sep 13, 1989
MODEL 6888 LEAD TUNNELER
K894738 · DWS
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 13, 1989
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761 · CGJ
Hybritech, Inc.
Chemistry · 48d
Cleared Sep 13, 1989
MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT
K894787 · FPA
New York Blood Center, Inc.
General Hospital · 44d
Cleared Sep 13, 1989
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
K894975 · KTN
General Biometrics, Inc.
Immunology · 37d
Cleared Sep 13, 1989
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · HTY
Buckman Co., Inc.
Orthopedic · 30d
Cleared Sep 12, 1989
THE SAFEGARD PERSONAL PROTECTION KIT
K884692 · HIS
The Safegard Protection Corp.
Obstetrics & Gynecology · 307d
Cleared Sep 12, 1989
MODIFIED URINARY CATHETER INTRODUCER (UCI)
K890400 · KOD
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 231d
Cleared Sep 12, 1989
GUIDEWIRE
K890959 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 197d