FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
115585–115608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1993
REFRACTROL-SP
K926095 · JJX
Medical Specialties, Inc.
Chemistry · 55d
Cleared Jan 26, 1993
BBL PYR REAGENT DROPPERS
K926254 · JTO
Becton Dickinson Microbiology Systems
Microbiology · 39d
Cleared Jan 26, 1993
BBL NITRATE A, B REAGENT DROPPERS
K926255 · JTO
Becton Dickinson Microbiology Systems
Microbiology · 39d
Cleared Jan 26, 1993
BBL NINHYDRIN REAGENT DROPPERS
K926256 · JTO
Becton Dickinson Microbiology Systems
Microbiology · 39d
Cleared Jan 26, 1993
LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST
K926308 · LCX
Princeton Biomedix
Chemistry · 42d
Cleared Jan 22, 1993
DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT
K914520 · GEX
Dio-Med Corp.
General & Plastic Surgery · 470d
Cleared Jan 22, 1993
PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC
K915251 · LYY
Supermax Sdn Bhd
General Hospital · 436d
Cleared Jan 22, 1993
SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K920333 · DPW
Koven and Assoc., Inc.
Cardiovascular · 361d
Cleared Jan 22, 1993
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
K920822 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 333d
Cleared Jan 22, 1993
DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK
K922074 · FRN
Danby Medical , Ltd.
General Hospital · 263d
Cleared Jan 22, 1993
ODYSSEY
K922810 · BTM
O-Two Systems Intl., Inc.
Anesthesiology · 226d
Cleared Jan 22, 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972 · DTB
Intermedics, Inc.
Cardiovascular · 217d
Cleared Jan 22, 1993
TENDERLETT FINGER
K923302 · FMK
International Technidyne Corp.
General & Plastic Surgery · 200d
Cleared Jan 22, 1993
BREAST SHELLS
K923577 · HFS
Medela, Inc.
General Hospital · 186d
Cleared Jan 22, 1993
BIPOLAR COAGULATOR/IRRIAGATION SYSTEM
K923928 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 170d
Cleared Jan 22, 1993
CABOT DISPOSABLE 10MM SUCTION DEVICE
K924048 · GCJ
Cabot Medical Corp.
General & Plastic Surgery · 164d
Cleared Jan 22, 1993
PHONOCARDIOGRAPH
K924054 · DQC
Echo Ultrasound
Cardiovascular · 163d
Cleared Jan 22, 1993
THE TRIAGE II
K924476 · DKZ
Biosite Incorporated
Toxicology · 141d
Cleared Jan 22, 1993
MASS SPECTROMETRY MONITORING LINE CONONECTORS
K925167 · CCK
Merit Medical Systems, Inc.
Anesthesiology · 101d
Cleared Jan 22, 1993
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT
K925232 · CAI
Merit Medical Systems, Inc.
Anesthesiology · 98d
Cleared Jan 22, 1993
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · CBK
Merit Medical Systems, Inc.
Anesthesiology · 95d
Cleared Jan 22, 1993
PASSAGE HEMOSTASIS VALVE
K925419 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 87d
Cleared Jan 22, 1993
SD-602 SD MODE 11, SD-603 SD MOD 111
K925729 · GZJ
Skylark Device Co., Ltd.
Neurology · 70d
Cleared Jan 21, 1993
HAND PACK
K914934 · KDO
Westmark Hospital Supplies
Gastroenterology & Urology · 444d