FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91513–91536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1997
GERM TRAPPER SUCTION TUBE HOLDER
K972372 · JOL
Rzv Medical Specialties, Inc.
General Hospital · 169d
Cleared Dec 11, 1997
CRIT-LINE MONITOR (CLMIII)
K972470 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 163d
Cleared Dec 11, 1997
COURIER ST BALLOON DILATATION CATHETER
K972744 · LIT
Boston Scientific Corp
Cardiovascular · 141d
Cleared Dec 11, 1997
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
K972887 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 128d
Cleared Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW...
K972979 · FBO
Smith & Nephew, Inc.
Gastroenterology & Urology · 122d
Cleared Dec 11, 1997
EXPRESSE AND PREMIER POWERED BREAST PUMPS
K973501 · HGX
Ameda Medizintechnik AG
Obstetrics & Gynecology · 86d
Cleared Dec 11, 1997
SOWELL COBALT-CHROME METAL ALLOY
K973567 · EJH
C.K. International Trading
Dental · 83d
Cleared Dec 11, 1997
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY
K973568 · EJH
C.K. International Trading
Dental · 83d
Cleared Dec 11, 1997
SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY
K973569 · EJH
C.K. International Trading
Dental · 83d
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