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
101233–101256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1995
BOSWORTH RESIN II
K953119 · EBI
Bosworth Co.
Dental · 56d
Cleared Aug 28, 1995
MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY
K953174 · GEX
Microquartz Medical, Inc.
General & Plastic Surgery · 52d
Cleared Aug 28, 1995
DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
K953206 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 90d
Cleared Aug 28, 1995
LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH
K953243 · GCJ
Devmed Group, Inc.
General & Plastic Surgery · 48d
Cleared Aug 28, 1995
ADI STERILE GAUZE SPONGES
K953501 · EFQ
Asia Dynamics, Inc.
General & Plastic Surgery · 33d
Cleared Aug 28, 1995
ULTRADENT FLOWABLE COMPOSITE
K953525 · EBF
Ultradent Products, Inc.
Dental · 32d
Cleared Aug 28, 1995
SNIP INPUT COMPRESSION CLASS A
K953631 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 42d
Cleared Aug 28, 1995
UNITRON MODEL IKON AOHPL
K953646 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 28, 1995
DCURASOL GEL WOUND DRESSING
K953816 · MGQ
Dpt Laboratories, Ltd.
General & Plastic Surgery · 13d
Cleared Aug 25, 1995
HEAD IMMOBILIZATION APPARATUS
K941118 · IYE
Northwest Medical Physics Center
Radiology · 536d
Cleared Aug 25, 1995
NEWPORT ELECTRONIC MANOMETER
K941308 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 536d
Cleared Aug 25, 1995
SB ANCHOR
K942889 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 431d
Cleared Aug 25, 1995
OXYLOG 2000
K943531 · CBK
Drager, Inc.
Anesthesiology · 400d
Cleared Aug 25, 1995
UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K943725 · KWQ
Synthes Spine
Orthopedic · 389d
Cleared Aug 25, 1995
W&H AIR MOTOR A25
K944711 · EFB
A-Dec, Inc.
Dental · 336d
Cleared Aug 25, 1995
W&H MICRO MOTOR E25 (WITHOUT LIGHT)
K944712 · EFB
A-Dec, Inc.
Dental · 336d
Cleared Aug 25, 1995
W&H CORSAIR SCALER
K944714 · EFB
A-Dec, Inc.
Dental · 336d
Cleared Aug 25, 1995
TAMPON, UNTREATED
K950194 · HEB
Hygieia Healthcare , Ltd.
Obstetrics & Gynecology · 219d
Cleared Aug 25, 1995
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · GKZ
Coulter Corp.
Hematology · 189d
Cleared Aug 25, 1995
STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
K950824 · FMF
Stryker Corp.
General Hospital · 183d
Cleared Aug 25, 1995
PARAGON POSTERIOR SPINAL SYSTEM
K950955 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 176d
Cleared Aug 25, 1995
EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
K951232 · HWC
American Medical Electronics, Inc.
Orthopedic · 158d
Cleared Aug 25, 1995
AURAFLEX TG-AB AND TPO-AB
K951320 · JNL
Organon Teknika Corp.
Immunology · 155d
Cleared Aug 25, 1995
ACE BONE SCREW TACKING KIT
K951510 · DZL
Ace Surgical Supply Co., Inc.
Dental · 144d