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
161689–161712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1982
ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW
K820401 · JPK
Orhto Diagnostic Systems, Inc.
Hematology · 31d
Cleared Mar 15, 1982
EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO
K820440 · LDN
Syva Co.
Toxicology · 26d
Cleared Mar 15, 1982
CENTRIFREE MICROPARTITION SYSTEM
K820455 · JRL
Amicon, Inc.
Chemistry · 24d
Cleared Mar 15, 1982
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · DTM
C.R. Bard, Inc.
Cardiovascular · 24d
Cleared Mar 15, 1982
IDA RAPID O2A SYSTEM
K820483 · JSP
Innovative Diagnostic Systems, Inc.
Microbiology · 21d
Cleared Mar 15, 1982
TENS MODEL 8201
K820496 · GZJ
Medical Scientific Instruments
Neurology · 20d
Cleared Mar 15, 1982
SILOAM SAVE-A-NEEDLE
K820502 · GAA
Siloam, Inc.
General & Plastic Surgery · 18d
Cleared Mar 15, 1982
CHORIO-QUANT
K820523 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 17d
Cleared Mar 15, 1982
RAICHEM GPT (ALT) REAGENT
K820525 · CKA
Reagents Applications, Inc.
Chemistry · 17d
Cleared Mar 15, 1982
RELIEVED REINFORCED CUP
K820539 · DXQ
Biomet, Inc.
Cardiovascular · 13d
Cleared Mar 15, 1982
POWERED TREADMILL
K820548 · IOL
Ogden Health Products
Physical Medicine · 13d
Cleared Mar 15, 1982
MECHANICAL CHAIR
K820591 · LBE
Kaye Products, Inc.
Physical Medicine · 11d
Cleared Mar 12, 1982
EAST AUTOCLAVE HUMIDIFIER
K812957 · BTT
Cairco , Ltd.
Anesthesiology · 142d
Cleared Mar 12, 1982
DISP. HYPERINFLATION BAG SYSTEM
K813317 · NHK
Intec Medical, Inc.
Anesthesiology · 108d
Cleared Mar 12, 1982
THERMASCAN
K813547 · KXZ
Bcd Products, Inc.
Radiology · 81d
Cleared Mar 12, 1982
PERMANENT & TEMPORARY PACEMAKER ELECTR.
K820262 · DTB
Diag Corp.
Cardiovascular · 38d
Cleared Mar 12, 1982
CLINIFLOW II, #701, ELECTROMAGN. BLD. SY
K820272 · DPW
Carolina Medical Electronics
Cardiovascular · 38d
Cleared Mar 12, 1982
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · DTL
C.R. Bard, Inc.
Cardiovascular · 36d
Cleared Mar 12, 1982
MONITRON MODEL JL-7
K820353 · CAP
Florida Medical Equipment Repair, Inc.
Anesthesiology · 32d
Cleared Mar 12, 1982
ANESTHESIA VENTILATOR
K820393 · CBK
Puritan Bennett Corp.
Anesthesiology · 29d
Cleared Mar 12, 1982
PATIENT FOLLOW-UP COMPUTER (PFC
K820402 · DXN
Medical Systems, Inc.
Cardiovascular · 28d
Cleared Mar 12, 1982
AEGIS NON-ADHERENT DRESSING
K820413 · NAB
Professional Medical Products, Inc.
General & Plastic Surgery · 28d
Cleared Mar 12, 1982
IMPACT, MODEL 310
K820424 · GCX
Impact Instrumentation, Inc.
General Hospital · 24d
Cleared Mar 12, 1982
HEART-ALERT
K820444 · KHX
Medical Equipment Devices, Inc.
Physical Medicine · 22d