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
171601–171624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1978
XOMED TRANSSPHENOIDAL HANDPIECE
K781418 · ERL
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Aug 31, 1978
DUAL COMPONENT STANDARDS
K781423 · JIT
Abbott Laboratories
Chemistry · 14d
Cleared Aug 31, 1978
HAND-TROL CONNECTOR EXTENDER
K781429 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 10d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 975
K781434 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 10d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 958
K781439 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 13d
Cleared Aug 23, 1978
PORTABLE CLOSED WOUND SUCTION EVACUATOR
K780848 · GCY
Biomet, Inc.
General & Plastic Surgery · 92d
Cleared Aug 23, 1978
SEARLE NEONATAL OXYGEN PROBE
K780850 · CCE
Will Ross Co.
Anesthesiology · 93d
Cleared Aug 23, 1978
NEEDLES, DESIGN CHANGE, IV CATHETERS
K780896 · GCB
Jelco Laboratories
General & Plastic Surgery · 85d
Cleared Aug 23, 1978
C-DAK 4000 ARTIFICIAL KIDNEY
K781058 · FJI
Cordis Corp.
Gastroenterology & Urology · 61d
Cleared Aug 23, 1978
ACCESSORY TO ECG ANALYSIS SYS.
K781130 · OMC
Oxford Medilog, Inc.
Neurology · 49d
Cleared Aug 23, 1978
ANALYZER, PACER SYSTEM, PSA-5
K781144 · DTC
Edwards Pacemaker Systems
Cardiovascular · 44d
Cleared Aug 23, 1978
DILUTION KIT, THERMAL, COLD PAC
K781221 · DRC
Instrumentation Laboratory CO
Cardiovascular · 37d
Cleared Aug 23, 1978
TECA VS6 VIDEO STIMULATOR
K781398 · GWE
Teca, Inc.
Neurology · 8d
Cleared Aug 21, 1978
DISPOSA-LOOPS
K780548 · KKX
Medi-Spec
General Hospital · 138d
Cleared Aug 21, 1978
MODEL 65 HIGH & LOW PRESSURE ALARM
K780863 · CAP
The John Bunn Co.
Anesthesiology · 83d
Cleared Aug 21, 1978
MAGNETIC DRAPE - INSTRUMENT HOLDER
K780865 · KKX
Devon Industries, Inc.
General Hospital · 83d
Cleared Aug 21, 1978
LEE-ALLOY DISPOSABLE CAPSULES
K780966 · DZS
Lee Pharmaceuticals
Dental · 70d
Cleared Aug 21, 1978
DATA TERMINAL MODEL 722
K781217 · JQP
Corning Medical & Scientific
Chemistry · 35d
Cleared Aug 21, 1978
ALLOY, AMALGAM, DISP. CAPSULE
K781242 · EJJ
Lee Pharmaceuticals
Dental · 70d
Cleared Aug 21, 1978
BUN (UREASE) REAGENT
K781253 · CDN
Coulter Electronics, Inc.
Chemistry · 31d
Cleared Aug 21, 1978
CEMENT, DENTAL/CAVITY LINER
K781281 · EMA
Star Dental Mfg. Co.
Dental · 26d
Cleared Aug 21, 1978
ELECTRODE, NEEDLE, CFM
K781311 · GXZ
Applied Medical Research
Neurology · 21d
Cleared Aug 21, 1978
OPTION PHO/SONIC B-MODE SCANNER
K781344 · IYO
G.D. Searle and Co.
Radiology · 17d
Cleared Aug 21, 1978
CAMCO QUIK STAIN II
K781347 · IAF
Cambridge Chemical Products, Inc.
Hematology · 14d