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
121609–121632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1991
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
K910564 · FOZ
Menlo Care, Inc.
General Hospital · 87d
Cleared May 06, 1991
TOUCHLESS II INTERMITTENT CATHETER
K910653 · FCM
C.R. Bard, Inc.
Gastroenterology & Urology · 81d
Cleared May 06, 1991
BIOTROL PROTEIN MULTILEVEL STANDARDS
K910721 · JIS
Biotrol, USA, Inc.
Chemistry · 75d
Cleared May 06, 1991
OPTHLAMIC FRAMES
K910951 · HQZ
United Optical, Spa
Ophthalmic · 62d
Cleared May 06, 1991
MULTIPLE, SURGICAL DRAPE PACK
K911132 · FZI
Central Georgia Ancillary Health Systems
General & Plastic Surgery · 53d
Cleared May 06, 1991
SPECTACLE FRAME
K911332 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 41d
Cleared May 06, 1991
CLEARBLUE EASY
K911566 · LCX
Unipath , Ltd.
Chemistry · 27d
Cleared May 03, 1991
VARIAN ELECTRONIC PORTAL IMAGING SYSTEM
K901932 · IYE
Varian Assoc., Inc.
Radiology · 368d
Cleared May 03, 1991
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
K905235 · CBK
Percussionaire Corp.
Anesthesiology · 177d
Cleared May 03, 1991
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K905635 · BSZ
Ohmeda Medical
Anesthesiology · 137d
Cleared May 03, 1991
STATIM CASSETTE AUTOCLAVE
K910241 · FLE
Scican
General Hospital · 101d
Cleared May 03, 1991
MENTOR LUBRICATING JELLY
K910790 · KMJ
Mentor Corp.
General Hospital · 67d
Cleared May 03, 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · CBK
Ohmeda Medical
Anesthesiology · 66d
Cleared May 03, 1991
MOSS P.E.G. TRAY
K910911 · KNT
Moss Medical Products
Gastroenterology & Urology · 59d
Cleared May 03, 1991
Z XT RADIATION THERAPY TREATMENT TABLE
K910971 · JAI
Siemens Medical Laboratories, Inc.
Radiology · 57d
Cleared May 03, 1991
SAFETY NEEDLE SHEATH, MODIFICATION
K911037 · FMI
Concord/Portex
General Hospital · 63d
Cleared May 03, 1991
ALADAN LATEX MEDICAL GLOVE
K911774 · LYY
Aladan Corp.
General Hospital · 14d
Cleared May 02, 1991
MODEL 205 SHOCK-TRODE
K910661 · DRO
Cardiotronics, Inc.
Cardiovascular · 78d
Cleared May 02, 1991
HOT BIOPSY FORCEPS
K910964 · KGE
Symbiosis Corp.
Gastroenterology & Urology · 57d
Cleared May 02, 1991
MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305
K911160 · GEI
Mentor O & O, Inc.
General & Plastic Surgery · 48d
Cleared May 01, 1991
MSTIM-2000 EMS
K904332 · IPF
Oms Medical Supplies, Inc.
Physical Medicine · 222d
Cleared May 01, 1991
SLEEPER MASK SYSTEM
K904344 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 219d
Cleared May 01, 1991
UNI-SEM(TM)
K910317 · MFD
Unimar, Inc.
Obstetrics & Gynecology · 97d
Cleared May 01, 1991
SERIM PERACETIC ACID REAGENT STRIPS
K910320 · JOJ
Serim Research Corp.
General Hospital · 97d