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
104881–104904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1995
ALLDRESS MULTI LAYERED WOUND DRESSING
K945206 · KMF
Scott Health Care
General & Plastic Surgery · 79d
Cleared Jan 12, 1995
SPARTA HYDROGEL WOUND DRESSING
K945313 · MGQ
Sparta Surgical Corp.
General & Plastic Surgery · 72d
Cleared Jan 12, 1995
ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS
K945545 · GCJ
Access Surgical Intl., Inc.
General & Plastic Surgery · 59d
Cleared Jan 12, 1995
POWERR RANGERS SUNGLASSES
K945917 · HQY
Dollar Land Stores, Inc.
Ophthalmic · 38d
Cleared Jan 12, 1995
LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS
K945960 · EFQ
Lorons International Corp.
General & Plastic Surgery · 36d
Cleared Jan 12, 1995
SUNGLASSES
K945988 · HQY
R.J. Standard Corp.
Ophthalmic · 35d
Cleared Jan 12, 1995
CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS
K946269 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 20d
Cleared Jan 12, 1995
BIOSTRIP STERILE WOUND CLOSURE STRIP
K946321 · FPX
Cornelia Damsky, Inc.
General & Plastic Surgery · 15d
Cleared Jan 11, 1995
GUARDPORT
K921478 · KNT
Health Improvement Assoc.
Gastroenterology & Urology · 1017d
Cleared Jan 11, 1995
HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS
K921525 · LPH
Implant Technology, Inc.
Orthopedic · 1013d
Cleared Jan 11, 1995
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
K925406 · FGE
Schneider Intl., Ltd.
Gastroenterology & Urology · 807d
Cleared Jan 11, 1995
BAXTER CA DIALYZER
K926567 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 741d
Cleared Jan 11, 1995
HEART 1001
K931020 · DXH
Aerotel, Ltd.
Cardiovascular · 684d
Cleared Jan 11, 1995
SNORING MICROPHONE, SM1
K940015 · MNR
Pro-Tech, Inc.
Anesthesiology · 372d
Cleared Jan 11, 1995
OLYMPUS NASAL AND SINUS ENDOSCOPES
K944072 · EOB
Olympus America, Inc.
Ear, Nose, Throat · 142d
Cleared Jan 11, 1995
PISTON SYRINGES
K944757 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 106d
Cleared Jan 11, 1995
ROYALSHIELD NON-STERILE POWDER-FREE
K945031 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 90d
Cleared Jan 11, 1995
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
K945103 · GZB
Medtronic Vascular
Neurology · 85d
Cleared Jan 11, 1995
POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)
K945142 · ELW
Scican
Dental · 83d
Cleared Jan 11, 1995
AMALGAM CARRIER
K945220 · EKI
Buffalo Dental Mfg. Co., Inc.
Dental · 77d
Cleared Jan 11, 1995
RISTOCETIN COFACTOR ASSAY KIT
K945414 · GGP
Chrono-Log Corp.
Hematology · 65d
Cleared Jan 11, 1995
DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)
K945830 · EFQ
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 43d
Cleared Jan 11, 1995
TUBING, NONINVASIVE
K945978 · GAZ
Endoscopic Technologies, Inc.
General Hospital · 34d
Cleared Jan 11, 1995
MALA LATEX EXAM GLOVES AND SCAN-SUB
K946154 · LYY
Lowenkamp Intl., Inc.
General Hospital · 26d