Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81505–81528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2000
MICROPAQ, MODELS 402 AND 404
K002725 · DRT
Protocol Systems, Inc.
Cardiovascular · 82d
Cleared Nov 21, 2000
K-DEFIB/PACE, MODEL KDP-60A
K002806 · MKJ
Katecho, Inc.
Cardiovascular · 74d
Cleared Nov 21, 2000
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 74d
Cleared Nov 21, 2000
MODEL 6600GE-64: TRAMA NECK ARRAY
K002864 · MOS
Midwest Rf, LLC
Radiology · 69d
Cleared Nov 21, 2000
MINITUB MULTI-PURPOSE CASSETTES
K002961 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 60d
Cleared Nov 21, 2000
SPECIALTY TINT SOFT CONTACT LENS
K003079 · LPL
Specialty Tint
Ophthalmic · 49d
Cleared Nov 21, 2000
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K003109 · LPN
Allergan, Inc.
Ophthalmic · 48d
Cleared Nov 21, 2000
CLINIFLO INCENTIVE SPIROMETER
K003146 · BWF
Dhd Healthcare Corp.
Anesthesiology · 42d
Cleared Nov 21, 2000
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
K003298 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 32d
Cleared Nov 21, 2000
RENEW LS-1
K003317 · EBF
Bisco, Inc.
Dental · 28d
Cleared Nov 21, 2000
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · DYB
Terumo Medical Corp.
Cardiovascular · 18d
Cleared Nov 21, 2000
MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
K003444 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 15d
Cleared Nov 20, 2000
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · CFR
Pointe Scientific, Inc.,
Chemistry · 123d
Cleared Nov 20, 2000
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605 · JDW
Synthes (Usa)
Orthopedic · 90d
Cleared Nov 20, 2000
PURESPERM 40 AND PURESPERM 80
K002623 · MQL
Nidacon International AB
Obstetrics & Gynecology · 89d
Cleared Nov 20, 2000
SILMAX CONTOUR CARVING BLOCK IMPLANT
K002629 · JOF
Pillar Surgical, Inc.
Ear, Nose, Throat · 89d
Cleared Nov 20, 2000
RADIAL HEAD IMPLANT
K002644 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 88d
Cleared Nov 20, 2000
N LATEX B2-MICROGLOBULIN
K002731 · JZG
Dade Behring, Inc.
Immunology · 80d
Cleared Nov 20, 2000
BAYONET FORCEPS BIPOLAR IRRIGATING
K002752 · GEI
Q2 Medical
General & Plastic Surgery · 76d
Cleared Nov 20, 2000
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098 · JIT
Beckman Coulter, Inc.
Chemistry · 48d
Cleared Nov 20, 2000
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
K003184 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 40d
Cleared Nov 20, 2000
MAGNA TEK ESU-400
K003471 · GEI
Huttinger Medizintechnik GmbH & CO KG
General & Plastic Surgery · 12d
Cleared Nov 17, 2000
VAGINAL APPLICATOR SHIELDED
K001544 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 183d
Cleared Nov 17, 2000
MEDPOR PTERIONAL SURGICAL IMPLANT
K002586 · MNF
Porex Surgical Products Group
General & Plastic Surgery · 88d