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
93745–93768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1997
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K965095 · LZA
Ansell Edmont Industrial, Inc.
General Hospital · 124d
Cleared Apr 22, 1997
VINYL EXAM GLOVE POWERED
K970144 · LYZ
Hiyi Export Co.
General Hospital · 97d
Cleared Apr 22, 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · KPI
Empi
Gastroenterology & Urology · 85d
Cleared Apr 22, 1997
EQUI-PISE 1000 MRS
K970350 · FNM
Advanced Air Support Consultancy, Inc.
General Hospital · 82d
Cleared Apr 22, 1997
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
K970394 · MEH
Osteonics Corp.
Orthopedic · 78d
Cleared Apr 22, 1997
SAFE-CONNECT I.V. EXTENSION SET
K970524 · FPA
Faulding Medical Device Co.
General Hospital · 70d
Cleared Apr 22, 1997
COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
K970764 · OCX
Comeg Endoscopy
Gastroenterology & Urology · 50d
Cleared Apr 22, 1997
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
K970966 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 36d
Cleared Apr 21, 1997
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
K941707 · DEH
Ventana Medical Systems, Inc.
Immunology · 1111d
Cleared Apr 21, 1997
HUMAN PROTEIN S RID TEST KIT
K951640 · GGP
The Binding Site, Ltd.
Hematology · 742d
Cleared Apr 21, 1997
VAIL 3000 BED ENCLOSURE
K963589 · FNL
Vail Products, Inc.
General Hospital · 224d
Cleared Apr 21, 1997
JANUS I
K963863 · IYO
3D Ultrasound, Inc.
Radiology · 207d
Cleared Apr 21, 1997
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 179d
Cleared Apr 21, 1997
AESCULAP ANGLED NEUROENDOSCOPES
K964281 · GWG
Aesculap, Inc.
Neurology · 175d
Cleared Apr 21, 1997
IN THE EAR HEARING AID
K964898 · ESD
Keytone Hearing Laboratory
Ear, Nose, Throat · 136d
Cleared Apr 21, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
K965033 · MGA
Beckman Instruments, Inc.
Immunology · 125d
Cleared Apr 21, 1997
SOLO-SLED
K970090 · IXA
Solo-Sled, LLC
Radiology · 101d
Cleared Apr 21, 1997
GSI CANNULA WITH INTRODUCER
K970201 · DYB
General Surgical Innovations
Cardiovascular · 90d
Cleared Apr 21, 1997
VITALLIUM 2000 ALLOY
K970205 · EJH
Austenal, Inc.
Dental · 90d
Cleared Apr 21, 1997
ARTOS, DIPLOS SYSTEM
K970284 · KWY
Turnkey Intergration USA, Inc.
Orthopedic · 87d
Cleared Apr 21, 1997
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · MSJ
Beckman Instruments, Inc.
Chemistry · 87d
Cleared Apr 21, 1997
ULTRACELL NEURO SPONGES
K970328 · HBA
Ultracell Medical Technologies, Inc.
Neurology · 84d
Cleared Apr 21, 1997
ACUFEX DOUBLE ARMED SUTURE NEEDLE
K970416 · GAT
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 76d
Cleared Apr 21, 1997
RIGHT ANGLE LASER FIBERS
K970422 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 77d