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
80401–80424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 17, 2000
GALAXY
K003007 · EJT
Sterngold
Dental · 52d
Cleared Nov 17, 2000
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE,...
K003132 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 42d
Cleared Nov 17, 2000
RESUSCITAIRE RADIANT WARMER
K003335 · FMT
Hill-Rom Air-Shields
General Hospital · 23d
Cleared Nov 17, 2000
CT CORD IQ OPTION 1.0
K003408 · JAK
GE Medical Systems
Radiology · 15d
Cleared Nov 17, 2000
TISSUE SPECTROSCOPE
K992529 · DPW
Vital Medical , Ltd.
Cardiovascular · 478d
Cleared Nov 16, 2000
SILENT NIGHT V
K000253 · MNR
Sleep Solutions, Inc.
Anesthesiology · 294d
Cleared Nov 16, 2000
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · DXT
Medrad, Inc.
Cardiovascular · 169d
Cleared Nov 16, 2000
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · JPA
Dade Behring, Inc.
Hematology · 129d
Cleared Nov 16, 2000
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
K002447 · DKZ
American Bio Medica Corp.
Toxicology · 99d