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
155161–155184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1984
MED-OPEDIC SLEEP SYSTEM
K834344 · INX
Bemco Mattress Co.
Physical Medicine · 36d
Cleared Jan 17, 1984
NEW MOTHER'S WAY-BREAST PUMP
K834399 · HGY
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 34d
Cleared Jan 17, 1984
TECHMEDICA-HEWSON SHOULDER CLEAT
K834411 · HTN
Techmedica, Inc.
Orthopedic · 33d
Cleared Jan 17, 1984
CAMPY BRUCELLA AGAR PLATE
K834417 · JSJ
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
CDC ANAEROBE BLOOD AGAR PLATE
K834418 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
CTA MEDIUM TUBE
K834425 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
LOEFFLER MEDIUM TUBE
K834426 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
THIOGEL MEDIUM TUBE
K834427 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
HYDROPULSE(GROSSAN)
K834507 · IRP
Amrex-Zetron, Inc.
Physical Medicine · 27d
Cleared Jan 17, 1984
JAY CUSHION
K834517 · KIC
Jay Medical, Ltd.
Physical Medicine · 27d
Cleared Jan 17, 1984
VENTI-VOICE NASAL CATHETER
K834522 · ESE
Respiratory Support Products, Inc.
Ear, Nose, Throat · 27d
Cleared Jan 17, 1984
ENDOBRONCHIAL TWIN LUMEN TUBE
K834565 · BTS
Portex, Inc.
Anesthesiology · 20d
Cleared Jan 17, 1984
SWIVEL ADAPTOR W/ALARM PORT
K840015 · BZA
Portex, Inc.
Anesthesiology · 13d
Cleared Jan 13, 1984
3-DAY RELEASE OF ETHYLENE OXIDE DEVICE
K832352 · BSO
Parke-Davis Co.
Anesthesiology · 182d
Cleared Jan 13, 1984
OMNI-FAL I & II
K833009 · JJY
American Monitor Corp.
Chemistry · 129d
Cleared Jan 13, 1984
DOCTOR VELLETTE'S INJECTOR
K833426 · EJI
Deproco, Inc.
Dental · 101d
Cleared Jan 13, 1984
HDL EX-SEP PRECIPITATING REAGENT
K833431 · LBR
Preventive Diagnostics Corp.
Chemistry · 100d
Cleared Jan 13, 1984
X-RAY SHIELD
K833558 · EHB
Moyco Industries, Inc.
Radiology · 92d
Cleared Jan 13, 1984
ORTHO ELT-8/DS HEMATOLOGY ANALYZER
K833618 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 91d
Cleared Jan 13, 1984
UR/RITE SYSTEM
K833666 · JQW
Wright Laboratories, Inc.
Chemistry · 87d
Cleared Jan 13, 1984
ALBUMIN REAGENT CS-716
K833699 · CIX
Fisher Scientific Co., LLC
Chemistry · 87d
Cleared Jan 13, 1984
ACA THYROXINE ANALYTICAL TEST PACK
K833701 · LBH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 87d
Cleared Jan 13, 1984
NA/K FLUIDA PACK FOR NOVA 1 ANALYZER
K833712 · JGS
Fisher Scientific Co., LLC
Chemistry · 84d
Cleared Jan 13, 1984
ALKALINE PHOSPHATASE-RATE
K833744 · CJE
Seragen Diagnostics, Inc.
Chemistry · 79d