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
122209–122232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 01, 1991
SUNGLASSES
K910415 · HQY
K.M Optical Co.
Ophthalmic · 91d
Cleared May 01, 1991
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K910432 · LYC
Lifecore Biomedical, Inc.
Dental · 90d
Cleared May 01, 1991
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K910499 · LGC
Vitek Systems, Inc.
Microbiology · 85d
Cleared May 01, 1991
CIBA CORNING ACS FT4 IMMUNOASSAY
K910684 · CEC
Ciba Corning Diagnostics Corp.
Chemistry · 71d
Cleared May 01, 1991
SRI T3 IMMOENZYMETRIC ASSAY
K910737 · CDP
Serono-Baker Diagnostics, Inc.
Chemistry · 69d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
K910930 · DIF
Analytical Control Systems, Inc.
Chemistry · 56d
Cleared May 01, 1991
REAL TIME X-RAY IMAGING SYSTEM
K911082 · LMA
Siemens Medical Solutions USA, Inc.
Radiology · 51d
Cleared May 01, 1991
OPHTA SIL (R), LACHRYMAL INTUBATION SETS
K911109 · OKS
G.W.B. Intl., Ltd.
Ophthalmic · 58d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
K911167 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
K911168 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d