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
82033–82056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Jul 11, 2000
SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256...
K001324 · OLT
Neuro Scan Labs
Neurology · 76d
Cleared Jul 11, 2000
SCULPTURE FLOW
K001623 · EBF
Jeneric/Pentron, Inc.
Dental · 46d
Cleared Jul 11, 2000
NEEDLELESS TRANSFER DEVICE
K001831 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 25d
Cleared Jul 11, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
K001837 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 25d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K001861 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d
Cleared Jul 11, 2000
SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
K001863 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 22d
Cleared Jul 11, 2000
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC...
K990144 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 539d
Cleared Jul 10, 2000
SENSATION -VACUUM ASSIST DEVICES
K000124 · LKY
Prosurg, Inc.
Gastroenterology & Urology · 174d
Cleared Jul 10, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K001214 · LPN
Alcon Universal, Ltd.
Ophthalmic · 87d
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356 · DJC
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 10, 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · GAW
Ethicon, Inc.
General & Plastic Surgery · 54d
Cleared Jul 10, 2000
PEDIATRIC REFERENCE DATA
K001812 · KGI
Lunar Corp.
Radiology · 25d
Cleared Jul 10, 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Jul 10, 2000
INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
K994409 · DPK
Alfa Scientific Designs, Inc.
Toxicology · 195d
Cleared Jul 07, 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · DTK
Cordis Corp.
Cardiovascular · 179d
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7,...
K001063 · DYG
Baxter Healthcare Corp
Cardiovascular · 95d
Cleared Jul 07, 2000
PANORET, MODEL 1000A
K001111 · HKL
Cmt Medical Technologies, Ltd.
Ophthalmic · 92d
Cleared Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
K001143 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 88d
Cleared Jul 07, 2000
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD...
K001156 · KDI
Gambro Renal Products
Gastroenterology & Urology · 88d
Cleared Jul 07, 2000
ULTRA V THERAPEUTIC ULTRASOUND
K001166 · IMG
Excel Tech. , Ltd.
Physical Medicine · 88d
Cleared Jul 07, 2000
OPI BAND
K001167 · MVA
Orthomerica Products, Inc.
Neurology · 88d
Cleared Jul 07, 2000
EXTERNAL FIXATION ANCHOR PIN
K001228 · JDW
Immedica, Inc.
Orthopedic · 81d
Cleared Jul 07, 2000
SNIPER, MODEL OR-3872XX SERIES
K001251 · DQX
Nipro Medical Corp.
Cardiovascular · 79d