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
172177–172200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1978
CARROLL TENDON RETRIEVER
K772393 · GEN
Edward Weck, Inc.
General & Plastic Surgery · 133d
Cleared May 09, 1978
RYUSEI
K772424 · BWJ
Ercona Corp.
General Hospital · 132d
Cleared May 09, 1978
PHOTOCOAGULATOR LASER
K780345 · HQB
Cavitron Corp.
Ophthalmic · 69d
Cleared May 09, 1978
FETAL MONITORING SYSTEM
K780487 · HFO
Sonicaid, Inc.
Obstetrics & Gynecology · 43d
Cleared May 09, 1978
FILTER TUBE
K780519 · BSN
Jelco Laboratories
Anesthesiology · 39d
Cleared May 09, 1978
MYOCATH KIT
K780529 · DQO
Sorensen Research
Cardiovascular · 36d
Cleared May 09, 1978
BLOOD PRESSURE MODULE
K780571 · DRQ
C-V Monitors Corp.
Cardiovascular · 29d
Cleared May 09, 1978
DCG PREAMPLIFIER MODULE
K780572 · DRR
C-V Monitors Corp.
Cardiovascular · 29d
Cleared May 09, 1978
SHOE COVERS
K780590 · FXP
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 09, 1978
ISOLATION GOWN
K780605 · FYC
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 09, 1978
ULTRASONIC DIAGNOSTIC TRANSDUCER
K780651 · ITX
Hoffrel Instruments, Inc.
Radiology · 20d
Cleared May 09, 1978
STERILE 100% SILICONE FOLEY CATHETER
K780675 · KOD
Medline Industries, Inc.
Gastroenterology & Urology · 15d
Cleared May 09, 1978
STERILE CLOSED SYSTEM
K780676 · KOD
Medline Industries, Inc.
Gastroenterology & Urology · 15d
Cleared May 09, 1978
AIR MASSAGE SYSTEM
K780710 · IRP
Theracom C/O Arent, Fox, Kintner, Plotki
Physical Medicine · 12d
Cleared May 09, 1978
OTOSCOPE SPECULA
K780723 · EPY
Abco Dealers, Inc.
General & Plastic Surgery · 7d
Cleared May 09, 1978
FIGURETRIM
K780730 · ISB
Jay-Mar INternational Enterprises, IN
Physical Medicine · 7d
Cleared May 04, 1978
CBR-T3RIA KIT
K780499 · CDP
Clinical Bioresearch
Chemistry · 37d
Cleared May 04, 1978
BLOOD CULTURE MEDIA
K780615 · JSH
Meda Stat Diagnostics, Inc.
Microbiology · 21d
Cleared May 03, 1978
LYPOPROTEIN CHOLESTEROL TEST KIT
K780173 · JHM
Environmental Chemical Specialties
Chemistry · 90d
Cleared May 03, 1978
HEMO FEC
K780214 · KHE
Boehringer Mannheim Corp.
Hematology · 84d
Cleared May 03, 1978
SHIELD
K780263 · EJK
Lorvic Corp.
Dental · 75d
Cleared May 03, 1978
CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS.
K780372
Abbott Laboratories
Chemistry · 56d
Cleared May 03, 1978
BLOOD PUMP-MODE S10K
K780410 · FIR
3M Health Care, Sarns
Gastroenterology & Urology · 51d
Cleared May 03, 1978
LELECTIVE KINETIC SYSTEM-60
K780464 · JJE
Hycel, Inc.
Chemistry · 42d