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
79921–79944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2001
BALLOON CANNULA, SHORT, MODEL R65-985
K010510 · HET
A & A Medical, Inc.
Obstetrics & Gynecology · 84d
Cleared May 16, 2001
ACTIVEECG
K010587 · DRT
Active Corp.
Cardiovascular · 78d
Cleared May 16, 2001
SEA-LONG MEDICAL TREATMENT HOOD
K010659 · CBF
Sea-Long Medical Systems, Inc.
Anesthesiology · 71d
Cleared May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · MOS
Usa Instruments, Inc.
Radiology · 65d
Cleared May 16, 2001
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609,...
K010747 · NFB
Western Ent.
Anesthesiology · 64d
Cleared May 16, 2001
UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN...
K010881 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 54d
Cleared May 16, 2001
K-ASSAY HS-CRP CONTROLS
K011079 · DCK
Kamiya Biomedical Co.
Immunology · 37d
Cleared May 16, 2001
ELIPAR FREELIGHT
K011154 · EBZ
Espe Dental AG
Dental · 30d
Cleared May 16, 2001
E-Z EM PERCUPUMP 2001 CT INJECTOR
K011160 · JAK
E-Z-Em, Inc.
Radiology · 30d
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · JGS
Beckman Coulter, Inc.
Chemistry · 26d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH...
K011217 · DQO
Abbott Laboratories
Cardiovascular · 26d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared May 16, 2001
POWDER-FREE NITRILE EXAM GLOVE, BLUE
K011286 · LZA
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 19d
Cleared May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · JXM
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 15, 2001
GUIDANT RETRIEVER DEVICE
K001694 · DQY
Guidant Cardiac and Vascular Surgery
Cardiovascular · 347d
Cleared May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · GJS
Lifescan, Inc.
Hematology · 347d
Cleared May 15, 2001
DYNATRON STS
K010565 · LIH
Dynatronics Corp.
Neurology · 78d
Cleared May 15, 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · FRN
Baxter Healthcare Corp
General Hospital · 78d
Cleared May 15, 2001
RANDOX IGE
K010855 · DGC
Randox Laboratories, Ltd.
Immunology · 54d
Cleared May 15, 2001
POWER TILT AND RECLINE SYSTEM
K010917 · ITI
Sunrise Medical, Inc.
Physical Medicine · 49d
Cleared May 15, 2001
DYNATRON STS RX
K010948 · LIH
Dynatronics Corp.
Neurology · 47d
Cleared May 15, 2001
TAPER-LOCK DENTAL IMPLANT SYSTEM
K011038 · DZE
Sulzer Dental, Inc.
Dental · 40d
Cleared May 15, 2001
DISPOSABLE BENDING CANNULA PR-233Q
K011149 · ODD
The Olympus Optical Co.
Gastroenterology & Urology · 29d