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
175801–175824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1976
ULTRAZYME GT
K760025 · JPZ
Harleco
Chemistry · 73d
Cleared Aug 26, 1976
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER
K760055 · CFR
Smithkline Diagnostics, Inc.
Chemistry · 71d
Cleared Aug 26, 1976
APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)
K760151 · DTK
Edwards Laboratories
Cardiovascular · 56d
Cleared Aug 26, 1976
ANALYZER, GLUCOSE/UREA/CREATININE
K760211 · JJC
Instrumentation Laboratory CO
Chemistry · 45d
Cleared Aug 26, 1976
ACID BASE SYSTEM, RADIOMETER AUTOMATED
K760229 · CHL
The London Co.
Chemistry · 43d
Cleared Aug 26, 1976
PRINTER, IL 460
K760232 · JJQ
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Aug 26, 1976
TABLE, SAMPLE IL 461
K760233 · JJQ
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Aug 26, 1976
GLUCOSE REAGENT SYS, SIGMA PROCED. 115
K760247 · CFR
Sigma Chemical Co.
Chemistry · 38d
Cleared Aug 26, 1976
TEST, MACROGLOBULIN KIT (ALPHA2)
K760396
Kallestad Laboratories, Inc.
Immunology · 20d
Cleared Aug 26, 1976
REAGENT, P-NITROPHENYL PHOSPHATE
K760399 · CJE
J.T. Baker Chemical Co.
Chemistry · 20d
Cleared Aug 26, 1976
COCAINE KIT, TOXI-PAK
K760401 · DLN
J.T. Baker Chemical Co.
Toxicology · 20d
Cleared Aug 26, 1976
TAMPON, PLAYTEX 2 VERSION B
K760426 · HIL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 14d
Cleared Aug 26, 1976
NEBULIZER ADAPTER (AERMIST)
K760442 · CAF
Aerway Laboratories, Inc.
Anesthesiology · 10d
Cleared Aug 26, 1976
CARDIAC ELECTRODE
K760443 · DTB
Meadox Medicals, Div. Boston...
Cardiovascular · 10d
Cleared Aug 26, 1976
PHOTOCOAGULATOR, LOG 3 PORTABLE XENON
K760444 · HQB
Varian Assoc., Inc.
Ophthalmic · 10d
Cleared Aug 26, 1976
DENTAL PROPHYLAXIS UNIT ULTRASONIC
K760445 · ELC
Branson Ultrasonics Corp.
Dental · 10d
Cleared Aug 26, 1976
GOUFFON PIN, ADJUSTABLE
K760454 · JDW
Howmedica Corp.
Orthopedic · 10d
Cleared Aug 26, 1976
OBSTETRICAL PACK (VIGILON OB PACK)
K760455 · HHD
C.R. Bard, Inc.
Obstetrics & Gynecology · 10d
Cleared Aug 26, 1976
NOSE CLIP
K760461 · BXJ
Inspiron Corp.
Anesthesiology · 8d
Cleared Aug 26, 1976
TABLE, X-RAY, RFX CLASSICAL
K760466 · IXR
General Electric Co.
Radiology · 8d
Cleared Aug 26, 1976
PLETHYSMOGRAPH (MDI SYSTEM II)
K760504 · JOM
Marketing Development Intl.
Cardiovascular · 3d
Cleared Aug 23, 1976
SYRINGE, DISPOSABLE, ALL PLASTIC
K760004 · FMF
Stewart-Naumann Laboratories
General Hospital · 77d
Cleared Aug 23, 1976
SYRINGE, DISPOSABLE, GLASS & PLASTIC
K760005 · FMF
Stewart-Naumann Laboratories
General Hospital · 77d
Cleared Aug 23, 1976
CATHETER, SILICONE FOLEY (BARDEX)
K760093 · GBM
C.R. Bard, Inc.
Gastroenterology & Urology · 63d