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
131545–131568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1989
CHISELS- FREER, LUCAS, ALEXANDER, BISHOP
K891902 · KGD
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 19d
Cleared Apr 11, 1989
CMV-CUBE(TM)
K884842 · LFZ
Difco Laboratories, Inc.
Microbiology · 141d
Cleared Apr 11, 1989
MODIFIED VAS-CATH CATHETER REPAIR KIT
K890099 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 91d
Cleared Apr 11, 1989
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
K890920 · LZU
Eagle Vision, Inc.
Ophthalmic · 47d
Cleared Apr 11, 1989
MANAN BONE MARROW BIOPSY NEEDLE
K890925 · DWO
Manan Medical Products, Inc.
General & Plastic Surgery · 46d
Cleared Apr 11, 1989
MICROSCOPE KNOB COVER, STERILE, DISPOSABLE
K891001 · HRM
Prescott'S, Inc.
General & Plastic Surgery · 43d
Cleared Apr 11, 1989
PATIENT EXAMINATION GLOVE
K891128 · LYZ
Jensen Union Ent. Co., Ltd.
General Hospital · 39d
Cleared Apr 11, 1989
ACU-CURETTE
K891334 · FZS
Acuderm, Inc.
General & Plastic Surgery · 32d
Cleared Apr 11, 1989
VINYL EXAM GLOVES (MFG. AM GLOVES CO. LTD.)
K891566 · LYZ
Neo-Sigma, Inc.
General Hospital · 25d
Cleared Apr 11, 1989
VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.)
K891567 · LYZ
Neo-Sigma, Inc.
General Hospital · 25d
Cleared Apr 11, 1989
VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.)
K891568 · LYZ
Neo-Sigma, Inc.
General Hospital · 25d
Cleared Apr 11, 1989
AMMEX LATEX EXAMINATION GLOVES
K891850 · LYY
Ammex Corp.
General Hospital · 15d
Cleared Apr 11, 1989
SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX)
K891854 · LYY
Unidus Corp.
General Hospital · 15d
Cleared Apr 11, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K891860 · LYZ
Cypress Medical Products, Ltd.
General Hospital · 15d
Cleared Apr 11, 1989
RUBBER LATEX PATIENT EXAMINATION GLOVES
K891866 · LYY
Amsia Intl., Inc.
General Hospital · 15d
Cleared Apr 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891883 · LYY
China National Machinery & Equipment...
General Hospital · 14d
Cleared Apr 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891885 · LYY
Alfaseal Sdn. Bhd.
General Hospital · 14d
Cleared Apr 11, 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
K891907 · JCN
R&D Systems, Inc.
Hematology · 15d
Cleared Apr 10, 1989
CRACK-IT CANNABINOID SCREEN
K874390 · LDJ
Sakers, Inc.
Toxicology · 531d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD HERPES IGG TEST KIT
K884246 · LGC
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
K884247 · LFX
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248 · LFZ
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT
K884249 · LGD
Disease Detection International, Inc.
Microbiology · 181d
Cleared Apr 10, 1989
HTS 220 CARDIAC MONITOR
K884524 · DSI
Life Sensing Instrument Company, Inc.
Cardiovascular · 165d