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.

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

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175,820 results
137713–137736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1987
FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM
K873626 · JDI
Orthopedic Systems, Inc.
Orthopedic · 114d
Cleared Dec 31, 1987
KIRSCHNER UNICONDYLAR KNEE SYSTEM
K873970 · HSX
Kirschner Medical Corp.
Orthopedic · 93d
Cleared Dec 31, 1987
ENTERON LIVER BIOPSY TRAY
K874062 · KNW
Endovations
Gastroenterology & Urology · 87d
Cleared Dec 31, 1987
ENTERSCAN
K874081 · LWI
Pie Data Medical BV
Ear, Nose, Throat · 85d
Cleared Dec 31, 1987
AML CALCAR FEMORAL PROSTHESIS
K874100 · JDG
Depuy, Inc.
Orthopedic · 84d
Cleared Dec 31, 1987
QUICKTRACH
K874742 · BTO
Posey Co.
Anesthesiology · 43d
Cleared Dec 30, 1987
EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX
K870899 · ITX
Biosound, Inc.
Radiology · 300d
Cleared Dec 30, 1987
FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA
K872352 · HHR
Laser Media
Obstetrics & Gynecology · 196d
Cleared Dec 30, 1987
BCM DRY PACK BICARBONATE MIXER
K873166 · FIN
Specialty Dialysis Services
Gastroenterology & Urology · 141d
Cleared Dec 30, 1987
GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS
K873248 · OCZ
Medical Engineering Laboratory, Inc.
Gastroenterology & Urology · 138d
Cleared Dec 30, 1987
MSI 9000 SERIES BED
K873291 · FNL
Med Service, Inc.
General Hospital · 135d
Cleared Dec 30, 1987
RESERVOIR BAG
K873494 · FRN
Marquette Medical, Inc.
General Hospital · 121d
Cleared Dec 30, 1987
PUMP TUBING SET
K873495 · FRN
Marquette Medical, Inc.
General Hospital · 121d
Cleared Dec 30, 1987
AMBU RMT VALVE
K873579 · BWF
Ambu, Inc.
Anesthesiology · 118d
Cleared Dec 30, 1987
COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE
K873605 · LWM
Pain Prevention Laboratory, Inc.
Dental · 117d
Cleared Dec 30, 1987
CTI STRAIGHT STEM
K873627 · JDG
Orthopedic Systems, Inc.
Orthopedic · 113d
Cleared Dec 30, 1987
LAKE IRRIGATION TRAY
K873991 · FMI
Lake Medical Products, Inc.
General Hospital · 90d
Cleared Dec 30, 1987
PRIA-KIT (TM) PRIAPISM KIT S.S.
K874000 · GAA
Canton Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 30, 1987
PHARMASEAL WOUND IRRIGATION DEVICE
K874022 · FQH
American Pharmaseal Div. Ahsc
General Hospital · 89d
Cleared Dec 30, 1987
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · CEP
Diagnostic Products Corp.
Chemistry · 89d
Cleared Dec 30, 1987
CHEMO-PORT
K874184 · LJT
Hdc Corp.
General Hospital · 77d
Cleared Dec 30, 1987
DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
K874378 · DXN
Critikon Company, LLC
Cardiovascular · 65d
Cleared Dec 30, 1987
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
K874386 · JCN
R&D Systems, Inc.
Hematology · 65d
Cleared Dec 30, 1987
PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
K874405 · JOD
Pall Biomedical Products Co.
Cardiovascular · 63d