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
129481–129504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1989
HOUTS HYSTERECTOMY DRAIN
K894220 · GBW
Helix Medical, Inc.
General & Plastic Surgery · 66d
Cleared Aug 24, 1989
MEDPRIDE LATEX EXAMINATION GLOVES
K894569 · LYY
Transcorp
General Hospital · 34d
Cleared Aug 24, 1989
LATEX PATIENT EXAMINATION GLOVES
K894774 · LYY
American Rubber Industries
General Hospital · 28d
Cleared Aug 24, 1989
ANTI-SM MICROASSAY
K894894 · LJM
Diamedix Corp.
Immunology · 23d
Cleared Aug 23, 1989
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI
K891773 · KPI
Hollister, Inc.
Gastroenterology & Urology · 152d
Cleared Aug 23, 1989
CONTIMED II BIOFEEDBACK DEV TREAT OF URIN INCONTI
K891774 · HIR
Hollister, Inc.
Gastroenterology & Urology · 152d
Cleared Aug 23, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892043 · LYY
Mwe Asia America Industries Sdn
General Hospital · 145d
Cleared Aug 23, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892164 · LYZ
King Handy Five Corp.
General Hospital · 139d
Cleared Aug 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892170 · LYY
Pattana Latex Co., Ltd.
General Hospital · 140d
Cleared Aug 23, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K892171 · LYY
Soh King Neng & Sons Sdn Bhd
General Hospital · 140d
Cleared Aug 23, 1989
LATEX EXAMINATION GLOVES (WINTEX)
K892174 · LYY
Windwell Agencies Sdn. Bhd.
General Hospital · 140d
Cleared Aug 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892177 · LYY
Chem-Specialties Sdn Bhd
General Hospital · 140d
Cleared Aug 23, 1989
PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
K892358 · KPS
Adac Laboratories
Radiology · 139d
Cleared Aug 23, 1989
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK
K893655 · EJF
American Orthodontics
Dental · 100d
Cleared Aug 23, 1989
HIGH NOBLE, TYPE III DENTAL CASTING ALLOY
K893688 · EJT
Jelenko Co.
Dental · 99d
Cleared Aug 23, 1989
KALTOCARB WOUND DRESSING
K894347 · FRO
Calgon Vestal Div.
General & Plastic Surgery · 40d
Cleared Aug 23, 1989
SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES
K894354 · KGO
Safeskin Corp.
General Hospital · 40d
Cleared Aug 23, 1989
DIRECTABLE COAXIAL CATHETER SET
K894716 · GCJ
Cook Ob/Gyn
General & Plastic Surgery · 29d
Cleared Aug 23, 1989
IRRIGATOR STAND
K894891 · HDC
Commercial Products & Engineering Co.
Obstetrics & Gynecology · 22d
Cleared Aug 23, 1989
2ND SKIN NON-STICK MOIST BURN PADS
K894898 · FRO
Spenco Medical Corp.
General & Plastic Surgery · 22d
Cleared Aug 22, 1989
ABSORBABLE SURGICAL GUT SUTURE*
K885018 · GAL
United States Surgical, A Division of...
General & Plastic Surgery · 260d
Cleared Aug 22, 1989
INFRARED HEX
K890585 · ILY
Healthteam
Physical Medicine · 197d
Cleared Aug 22, 1989
INFRARED DELUXE
K890586 · ILY
Healthteam
Physical Medicine · 197d
Cleared Aug 22, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891136 · LYY
Advance Rubber, Inc.
General Hospital · 172d