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
165241–165264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1981
SODIUM & POTASSIUM TEST KIT
K810253 · JGM
Mallinckrodt Critical Care
Chemistry · 11d
Cleared Feb 10, 1981
EUROCHIMA UREA NITROGEN
K810261 · CDL
Volu Sol Medical Industries
Chemistry · 11d
Cleared Feb 09, 1981
POLY FLEX IMPLANTABLE PACING LEAD
K802295 · DTB
Intermedics, Inc.
Cardiovascular · 143d
Cleared Feb 09, 1981
TEST KIT FOR DETECTION OF HERPES SIMPLEX
K802526 · LGC
Bartels & Stout, Inc.
Microbiology · 117d
Cleared Feb 09, 1981
DIRECT FLUORESCENT ANTIBODY KIT/HERPES
K802590 · GQL
Bartels & Stout, Inc.
Microbiology · 117d
Cleared Feb 09, 1981
FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM
K803196 · HSB
Howmedica Corp.
Orthopedic · 55d
Cleared Feb 09, 1981
IMMUNOLOGY CONTROL SERUM
K810056 · DEW
Icl Scientific
Immunology · 27d
Cleared Feb 09, 1981
SCRIPPSERA ANA REFERENCE CONTROL SERA
K810081 · DHN
Scripps-Miles, Inc.
Immunology · 27d
Cleared Feb 09, 1981
CONTROL SERUMS FOR NONTREPONEMAL TEST
K810119 · GMP
Hillside Acres, Inc.
Toxicology · 24d
Cleared Feb 09, 1981
INERTIAL EXTENSILIZER CHIRO. ADJ. TABLE
K810125 · INQ
The Inertial Corp.
Physical Medicine · 21d
Cleared Feb 09, 1981
SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
K810141 · DHR
Scripps-Miles, Inc.
Immunology · 19d
Cleared Feb 09, 1981
VENTILATORY EFFORT MONITOR
K810153 · FLS
Medicon, Inc.
Anesthesiology · 19d
Cleared Feb 09, 1981
WILLIAMS OESOPHAGEAL VARICES INJECT TUBE
K810180 · FED
Keymed, Inc.
Gastroenterology & Urology · 18d
Cleared Feb 09, 1981
MECRON CANCELLOUS CANNULATED BONE SCREWS
K810205 · HWC
Serrano Intl.
Orthopedic · 14d
Cleared Feb 09, 1981
ARGYLE ROB-NELS
K810216 · KOD
Sherwood Medical Co.
Gastroenterology & Urology · 13d
Cleared Feb 09, 1981
SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
K810221 · DHR
Scripps-Miles, Inc.
Immunology · 13d
Cleared Feb 09, 1981
SLE ANTI-N-DNA LATEX TEST
K810226 · DHC
Icl Scientific
Immunology · 13d
Cleared Feb 09, 1981
SCEPTOR SYSTEM AUTOMATED MODEL 216
K810229 · JTC
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared Feb 09, 1981
DISPOSABLE PILLOW
K810264 · KME
Anago, Inc.
General Hospital · 7d
Cleared Feb 09, 1981
FEMORAL CANAL BRUSH
K810267 · LXH
Richard'S Medical Equip., Inc.
Orthopedic · 39d
Cleared Feb 06, 1981
HYDROPHILIC COATED CATHETER
K810023 · BSY
Bd Becton Dickinson Vacutainer...
Anesthesiology · 32d
Cleared Feb 06, 1981
CURITY CURAD BANDAGES
K810126 · KGX
The Kendal Co.
General & Plastic Surgery · 18d
Cleared Feb 06, 1981
ENDAB CORTISOL KIT
K810192 · CGR
Immunotech Corp.
Toxicology · 14d
Cleared Feb 05, 1981
PACEMAKER PATIENT MGMT. SYSTEM
K801810 · DQK
Siemens Elema AB
Cardiovascular · 190d