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
88129–88152 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1998
ALLDRESS, ABSORBENT FILM DRESSING
K983554 · KMF
Molnlycke Health Care, Inc.
General & Plastic Surgery · 28d
Cleared Nov 10, 1998
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
K983603 · HAW
Radionics, Inc.
Neurology · 27d
Cleared Nov 10, 1998
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
K983736 · CAF
Brasamerica Medical Equipment, Inc.
Anesthesiology · 19d
Cleared Nov 09, 1998
LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980800 · EBF
Cosmedent, Inc.
Dental · 252d
Cleared Nov 09, 1998
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
K981871 · DCK
Diagnostic Systems Laboratories, Inc.
Immunology · 165d
Cleared Nov 09, 1998
BRENEB
K982043 · CAF
Bremed Italia, S.R.L.
Anesthesiology · 152d
Cleared Nov 09, 1998
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K982167 · GKZ
Coulter Corp.
Hematology · 143d
Cleared Nov 09, 1998
BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE...
K982840 · IYO
Boston Scientific Corp
Radiology · 89d
Cleared Nov 09, 1998
FIBREKOR POST SYSTEM
K983266 · ELR
Jeneric/Pentron, Inc.
Dental · 53d
Cleared Nov 09, 1998
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
K983478 · HEB
Organic Essentials
Obstetrics & Gynecology · 38d
Cleared Nov 06, 1998
PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
K973585 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 410d
Cleared Nov 06, 1998
ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
K980895 · LFL
California Institute of Tissue Eng. &...
General & Plastic Surgery · 242d
Cleared Nov 06, 1998
ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
K980999 · JWH
Instrument Makar, Inc.
Orthopedic · 233d
Cleared Nov 06, 1998
QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS...
K981462 · ITI
Sunrise Medical, Inc.
Physical Medicine · 197d
Cleared Nov 06, 1998
ACE ALVEOLAR DISTRACTOR
K981526 · JEY
Ace Surgical Supply Co., Inc.
Dental · 192d
Cleared Nov 06, 1998
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL...
K982110 · LPL
Optech, Inc.
Ophthalmic · 143d
Cleared Nov 06, 1998
SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
K982410 · GZJ
Rehabilicare, Inc.
Neurology · 116d
Cleared Nov 06, 1998
IRRIGATION SYRINGE KIT
K982435 · KYZ
Sub-Q, Inc.
General Hospital · 116d
Cleared Nov 06, 1998
MESH, SURGICAL, POLYMERIC
K982575 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 105d
Cleared Nov 06, 1998
NATURALYTE, MODEL # 08-4004-1
K982813 · KPO
Kaybath, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 06, 1998
ALPHATRAC, MODEL A200
K982815 · ITI
Teftec Corp.
Physical Medicine · 87d
Cleared Nov 06, 1998
BRENNEN MEDICAL BETA GLUCAN GEL
K982825 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 87d
Cleared Nov 06, 1998
MEGA 2000
K982826 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 87d
Cleared Nov 06, 1998
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · IPF
Chattanooga Group, Inc.
Physical Medicine · 87d