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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91009–91032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1997
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K973778 · LYY
Hartalega Sdn Bhd
General Hospital · 69d
Cleared Dec 11, 1997
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL
K973781 · ELW
Dentsply Intl.
Dental · 69d
Cleared Dec 11, 1997
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
K973871 · LYY
Hartalega Sdn Bhd
General Hospital · 62d
Cleared Dec 11, 1997
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
K973927 · ESD
Hyunjae Corp.
Ear, Nose, Throat · 57d
Cleared Dec 11, 1997
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN...
K974181 · JXM
Princeton BioMeditech Corp.
Toxicology · 35d
Cleared Dec 11, 1997
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
K974261 · LJK
Boston Biomedica, Inc.
Microbiology · 28d
Cleared Dec 10, 1997
ALPHA MX (20)/ULTRA PC (30)
K970163 · BSZ
Technical Medical Products, Inc.
Anesthesiology · 328d
Cleared Dec 10, 1997
B.U.S. ENDOTRON
K972148 · LFL
Medicamat S.A.
General & Plastic Surgery · 184d
Cleared Dec 10, 1997
OSMOCYTE ISLAND WOUND DRESSING
K972150 · KMF
Procyte Corp.
General & Plastic Surgery · 184d
Cleared Dec 10, 1997
OSMOCYTE RA WOUND DRESSING
K972329 · KMF
Procyte Corp.
General & Plastic Surgery · 170d
Cleared Dec 10, 1997
INVOTEC CLEAN PAD
K973580 · EFQ
Invotec International, Inc.
General & Plastic Surgery · 82d
Cleared Dec 10, 1997
KENDALL CURITY NON-ADHERING DRESSING
K973619 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 78d
Cleared Dec 10, 1997
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL,...
K974461 · JJT
Biosite Incorporated
Chemistry · 15d
Cleared Dec 09, 1997
HEART PROTECTOR (VER 1996)
K965158 · DRT
N.P.N.T., Inc.
Cardiovascular · 351d
Cleared Dec 09, 1997
LYOPLANT DURA SUBSTITUTE(VARIOUS)
K970851 · GXQ
Aesculap, Inc.
Neurology · 277d
Cleared Dec 09, 1997
UAS ULTRASONIC ASPIRATOR SYSTEM
K971580 · LFL
Wells Johnson Co.
General & Plastic Surgery · 223d
Cleared Dec 09, 1997
PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER
K972496 · KNW
Tao & Tao Technologyt, Inc.
Gastroenterology & Urology · 159d
Cleared Dec 09, 1997
ULTRACELL NEURO SPONGES
K973083 · HBA
Ultracell Medical Technologies, Inc.
Neurology · 113d
Cleared Dec 09, 1997
CLINITEX STOCKINETTE
K973417 · LGF
Clinitex Medical Corp.
Orthopedic · 90d
Cleared Dec 09, 1997
CLINITEX CAST PADDING
K973420 · LGF
Clinitex Medical Corp.
Orthopedic · 90d
Cleared Dec 09, 1997
ENFRESH TONGUE BRUSH
K973424 · LCN
Enfresh Products, LLC
Dental · 90d
Cleared Dec 09, 1997
SURGIFLATOR-30
K973432 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 90d
Cleared Dec 09, 1997
VISTA HEAD MOUNTED DISPLAY
K973436 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Dec 09, 1997
OSTEO BOS SYSTEM PRODUCT LINE EXTENSION
K973438 · HRS
Osteonics Corp.
Orthopedic · 90d