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
95425–95448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1996
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
K963029 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 114d
Cleared Nov 27, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K963429 · LNH
GE Medical Systems
Radiology · 89d
Cleared Nov 27, 1996
REVISION HIP SYSTEM
K963486 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 85d
Cleared Nov 27, 1996
DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
K963487 · LPL
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Nov 27, 1996
INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS
K963598 · KMF
Innovative Technologies , Ltd.
General & Plastic Surgery · 79d
Cleared Nov 27, 1996
DERMAGRAN HYDROPHILIC OINTMENT
K963603 · KMF
Derma Sciences, Inc.
General & Plastic Surgery · 79d
Cleared Nov 27, 1996
AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES
K963610 · LLZ
A.L.I. Technologies, Inc.
Radiology · 78d
Cleared Nov 27, 1996
CD HORIZON ANTERIOR SPINAL SYSTEM
K963655 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 76d
Cleared Nov 27, 1996
EASYLYTE CALCIUM/CHLORIDE ANALYZER
K963694 · JFP
Medica Corp.
Chemistry · 72d
Cleared Nov 27, 1996
ADVANCED DIAGNOSTIC VIEWER (ADV)
K963697 · LLZ
Bio-Vascular, Inc.
Radiology · 72d
Cleared Nov 27, 1996
GRAND MEDICAL SUTURE REMOVAL KIT
K963714 · MCZ
Grand Medical Products
General & Plastic Surgery · 72d
Cleared Nov 27, 1996
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
K963715 · LRO
Grand Medical Products
General & Plastic Surgery · 72d
Cleared Nov 27, 1996
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
K963719 · MCY
Grand Medical Products
General & Plastic Surgery · 72d
Cleared Nov 27, 1996
TRACHEOSTOMY KIT
K963720 · LRQ
Grand Medical Products
General & Plastic Surgery · 72d
Cleared Nov 27, 1996
SKIN SCRUB TRAY
K963721 · LRO
Grand Medical Products
General & Plastic Surgery · 72d
Cleared Nov 27, 1996
IV START KIT
K963722 · LRS
Grand Medical Products
General & Plastic Surgery · 72d
Cleared Nov 27, 1996
LACERATION TRAY
K963723 · LRP
Grand Medical Products
General & Plastic Surgery · 72d
Cleared Nov 27, 1996
COJET SYSTEM
K963735 · EBF
Espe GmbH & Co. Kg.
Dental · 71d
Cleared Nov 27, 1996
PRIMOFOCUS COMPACT
K963788 · ESD
Oticon Corp.
Ear, Nose, Throat · 68d
Cleared Nov 27, 1996
SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM
K963798 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Nov 27, 1996
PRODIGY AC
K963805 · EBF
Sybron Dental Specialties, Inc.
Dental · 65d
Cleared Nov 27, 1996
AHS OMEGA K-AMP
K963875 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared Nov 27, 1996
THE PHARAOH COMPENSATING FILTER
K963941 · KPR
Octostop, Inc.
Radiology · 57d
Cleared Nov 27, 1996
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
K963999 · OCW
United States Surgical, A Division of...
Gastroenterology & Urology · 51d