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
152401–152424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1984
VINYL EXAM GLOVES, NON-STERILE
K843016
Abco Dealers, Inc.
General & Plastic Surgery · 17d
Cleared Aug 17, 1984
DISPOS. & SPONGE FORCEPS PEAN ARTERY
K843074 · GEN
Greene International Corp.
General & Plastic Surgery · 11d
Cleared Aug 17, 1984
AVA-NEB NEBULIZER
K843102 · CCQ
Avatron, Inc.
Anesthesiology · 10d
Cleared Aug 17, 1984
DISPOSABLE SKIN MARKING PEN
K843116 · FZZ
E.M. Adams
General & Plastic Surgery · 9d
Cleared Aug 17, 1984
ETI TENS BELT
K843119 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 9d
Cleared Aug 17, 1984
MICRO-TEMP PUMPS & MICRO-TEMP PADS
K843146 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 7d
Cleared Aug 16, 1984
HOLLOW FIBER DIALYZERS
K840845 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 174d
Cleared Aug 16, 1984
ACCU-CULT FECAL OCCULT BLOOD TEST
K840904 · KHE
Applied Medical Devices, Inc.
Hematology · 170d
Cleared Aug 16, 1984
PICOSCAL BLOOD CELL COUNTER PS-4
K842140 · GKL
Diagnostic Technology, Inc.
Hematology · 78d
Cleared Aug 16, 1984
CREATININE ASSAY KIT-KINETIC OR ENDPOINT
K842159 · CGX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 78d
Cleared Aug 16, 1984
TDX DIGITOXIN
K842280 · LFM
Abbott Laboratories
Toxicology · 69d
Cleared Aug 16, 1984
CORTI-COTE CORTISOL SOLID PHASE RADIO
K842365 · CGR
Bd Becton Dickinson Vacutainer...
Chemistry · 62d
Cleared Aug 16, 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · CGA
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 16, 1984
AXIOM STABLE II URIC ACID TEST
K842442 · KNK
Axiom, Inc.
Chemistry · 56d
Cleared Aug 16, 1984
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
K842449 · JIS
Hi Chem, Inc.
Chemistry · 55d
Cleared Aug 16, 1984
HICHEM ION 2/4 URINE RANGE CALIBRATOR
K842450 · JIS
Hi Chem, Inc.
Chemistry · 55d
Cleared Aug 16, 1984
AMER. BIO-SCIENCE LAB CORTISOL REAGENT
K842455 · CGR
American Bio-Science Laboratories
Chemistry · 55d
Cleared Aug 16, 1984
DATA MGMT. SYSTEM
K842500 · JJE
Gilford
Chemistry · 51d
Cleared Aug 16, 1984
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548 · LDP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 45d
Cleared Aug 16, 1984
ACA ACETAMINOPHEN CALIBRATOR
K842549
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 45d
Cleared Aug 16, 1984
IMMPULSE DIGOXIN ASSAY REAGENTS
K842571 · KXT
Aktis Corp.
Toxicology · 44d
Cleared Aug 16, 1984
EPSILON DIGOXIN TEST KIT
K842655 · KXT
Beckman Instruments, Inc.
Toxicology · 37d
Cleared Aug 16, 1984
STREPTEX DIRECT A ZL14
K842827 · GTZ
Wellcome Diagnostics
Immunology · 27d
Cleared Aug 15, 1984
COLOR OPTIC CORNEAL EYE SHIELD
K840414 · HOY
Diversations, Inc.
Ophthalmic · 197d