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
80905–80928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 17, 2000
CBS STRAW
K002595 · MQG
Cryo Bio System
Obstetrics & Gynecology · 88d
Cleared Nov 17, 2000
CN ACQUISITION STATION
K002597 · LLZ
Cardionow, Inc.
Radiology · 88d
Cleared Nov 17, 2000
DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
K002692 · FRF
Hmi Industries, Inc.
General Hospital · 80d
Cleared Nov 17, 2000
RACE ENDODONTIC FILE
K002709 · EFA
Amc General, Inc.
Dental · 79d
Cleared Nov 17, 2000
NUMALINK
K002724 · LLZ
Numa, Inc.
Radiology · 78d
Cleared Nov 17, 2000
VIATRONIX VISUALIZATION SYSTEM (VVS)
K002780 · LLZ
Viatronix, Inc.
Radiology · 72d
Cleared Nov 17, 2000
BIOSENSORS CENTRAL VENOUS CATHETER KITS
K002786 · FOZ
Sunscope Intl., Inc.
General Hospital · 71d
Cleared Nov 17, 2000
MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
K002840 · IZI
The Phantom Laboratory, Inc.
Radiology · 66d