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

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176,076 results
161377–161400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1982
DISSCAP 140
K820965 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
DISSCAP 110
K820966 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
ENDOSCOPIC INJECTION NEEDLE
K820973 · FBK
Mill-Rose Laboratory
Gastroenterology & Urology · 10d
Cleared Apr 16, 1982
POLYSONIC ULTRASOUND LOTION
K827296 · MUI
Parker Laboratories, Inc.
Radiology · 17d
Cleared Apr 15, 1982
DISPOSABLE PLASTIC SYRINGE W/NEEDLE
K813223 · DXG
Sam Joo Industrial Co., Ltd.
Cardiovascular · 157d
Cleared Apr 15, 1982
GLASS SYRINGES, DRUG, LUER LOCK
K820384 · FMF
Procedure Products, Inc.
General Hospital · 65d
Cleared Apr 15, 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · DSI
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Apr 15, 1982
ARTERIAL CANALIZATION DEVICE
K820516 · DQY
Alimed, Inc.
Cardiovascular · 49d
Cleared Apr 15, 1982
AUTOSPIROMETER HI-498
K820599 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 42d
Cleared Apr 15, 1982
INFANT MONITOR
K820645 · BZQ
Healthdyne, Inc.
Anesthesiology · 37d
Cleared Apr 15, 1982
PULSE GENERATOR 678 B
K820657 · DXY
Siemens Elema AB
Cardiovascular · 37d
Cleared Apr 15, 1982
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
K820681 · FSY
Sybron Corp.
General & Plastic Surgery · 35d
Cleared Apr 15, 1982
CENTRAL VENOUS ACCESS CATHETER
K820736 · DQY
Hemed, Inc.
Cardiovascular · 28d
Cleared Apr 15, 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · DPW
Nihon Kohden America, Inc.
Cardiovascular · 28d
Cleared Apr 15, 1982
IL MODEL 1301, PH BLOOD GAS SYSTEM
K820744 · CHL
Instrumentation Laboratory CO
Chemistry · 27d
Cleared Apr 15, 1982
MONOJECT SAF-T-LOCK
K820747 · FPA
Sherwood Medical Co.
General Hospital · 27d
Cleared Apr 15, 1982
AMERLEX ESH KIT
K820754 · CGJ
Amersham Corp.
Chemistry · 27d
Cleared Apr 15, 1982
ENZYM-LINKED T3
K820763 · CDP
Icl Scientific
Chemistry · 24d
Cleared Apr 15, 1982
IVAC MODEL 160 AIR-IN-LINE SENSOR
K820764 · FRN
Y
General Hospital · 24d
Cleared Apr 15, 1982
PLEURAL DRAINAGE RESERVOIR
K820765 · GCX
Innovative Surgical Products, Inc.
General Hospital · 24d
Cleared Apr 15, 1982
CANNUOATED TROCHAR
K820776 · HRX
The Anspach Effort, Inc.
Orthopedic · 23d
Cleared Apr 15, 1982
CASTLE MICROCOMPUTER STERILIZER CONTROL
K820783 · FLF
Sybron Corp.
General Hospital · 23d
Cleared Apr 15, 1982
CARDIAC MONITOR - RATE ALARM
K820825 · DRT
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Apr 15, 1982
PHOSPHORUS IL
K820832 · CED
American Monitor Corp.
Chemistry · 20d