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
136729–136752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1988
FERRIS HYDROPHILIC DRESSING
K880330 · FRO
Ferris Mfg. Corp.
General & Plastic Surgery · 56d
Cleared Mar 23, 1988
CLP PROTHROMBIN TIME TEST
K880566 · GJS
Creative Laboratory Products, Inc.
Hematology · 42d
Cleared Mar 23, 1988
MODIFICATIONS TO API UNISCEPT (R) KB
K880598 · JWY
Analytical Products, Inc.
Microbiology · 41d
Cleared Mar 23, 1988
CREATININE
K880629 · CGX
Tech-Co, Inc.
Chemistry · 36d
Cleared Mar 23, 1988
CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K881068 · GFO
Creative Laboratory Products, Inc.
Hematology · 9d
Cleared Mar 23, 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
K881125 · LIO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 7d
Cleared Mar 22, 1988
MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K872126 · DTB
Intermedics, Inc.
Cardiovascular · 294d
Cleared Mar 22, 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · DQX
Cordis Corp.
Cardiovascular · 211d
Cleared Mar 22, 1988
VITALOG HMS-3000
K874198 · DQA
Vitalog Corp.
Anesthesiology · 165d
Cleared Mar 22, 1988
BLOOD PRESSURE SLEEVE W/TUBING
K874233 · DXQ
Devcom, Inc.
Cardiovascular · 159d
Cleared Mar 22, 1988
INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
K874306 · LGM
Busse Hospital Disposables, Inc.
General Hospital · 154d
Cleared Mar 22, 1988
LAWRENCE L4000 REFLECTANCE PULSE OXIMETER
K874492 · DQA
Lawrence Medical Systems, Inc.
Anesthesiology · 141d
Cleared Mar 22, 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 104d
Cleared Mar 22, 1988
PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
K875353 · DWF
Dlp, Inc.
Cardiovascular · 82d
Cleared Mar 22, 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 71d
Cleared Mar 22, 1988
SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE
K880071 · FCS
Laserguide
Gastroenterology & Urology · 71d
Cleared Mar 22, 1988
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.
K880103 · DWF
Research Medical, Inc.
Cardiovascular · 70d
Cleared Mar 22, 1988
ANGIOPLASTY BALLOON INFLATION DEVICE
K880158 · LIT
L.O.N. Research, Inc.
Cardiovascular · 69d
Cleared Mar 22, 1988
STATFLO
K880180 · DWF
Imodex, Inc.
Cardiovascular · 69d
Cleared Mar 22, 1988
ELECTRODE CABLE
K880320 · DSA
Vital Connections, Inc.
Cardiovascular · 56d
Cleared Mar 22, 1988
MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
K880323 · DSA
Medtronic Vascular
Cardiovascular · 56d
Cleared Mar 22, 1988
VITAL SYSTEM
K880351 · DXN
Pace Tech, Inc.
Cardiovascular · 56d
Cleared Mar 22, 1988
MODIFIED NICOLET VIKING SYSTEM
K880573 · IKN
Nicolet Biomedical Instruments
Neurology · 41d
Cleared Mar 22, 1988
MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
K880740 · DQF
Spectramed, Inc.
General Hospital · 27d