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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
138985–139008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1987
VIRGO(TM) RUBELLA IGG ELISA
K873088 · LFX
Electro-Nucleonics Laboratories, Inc.
Microbiology · 35d
Cleared Sep 09, 1987
MMG CATH-N-PLACE
K873136 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 30d
Cleared Sep 09, 1987
CENTRAL SUPPLY ROOM WRAP
K873175 · FRG
Ulti-Med Intl., Inc.
General Hospital · 28d
Cleared Sep 09, 1987
ACROMED INTERBODY DEPTH GAUGES
K873191 · HTJ
Buckman Co., Inc.
Orthopedic · 27d
Cleared Sep 09, 1987
CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
K873347 · GIF
Abbott Diagnostics
Hematology · 20d
Cleared Sep 09, 1987
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348 · GGK
Abbott Diagnostics
Hematology · 20d
Cleared Sep 08, 1987
MOD 482
K870850 · JOP
Hoffrel Instruments, Inc.
Cardiovascular · 189d
Cleared Sep 08, 1987
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
K871865 · LNK
Sharplan Lasers, Inc.
Gastroenterology & Urology · 118d
Cleared Sep 08, 1987
MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER
K872302 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 85d
Cleared Sep 08, 1987
VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB
K872307 · IYO
General Electric Co.
Radiology · 84d
Cleared Sep 08, 1987
ANCHOR BIOPSY NEEDLE
K873124 · GAA
Anchor Products Co.
General & Plastic Surgery · 29d
Cleared Sep 08, 1987
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR
K873160 · CDT
Biotrol, USA, Inc.
Chemistry · 28d
Cleared Sep 08, 1987
ENDOSCOPY TABLE 1532 ENDOSTAR
K873272 · BWN
Stierlen-Maquet AG
General & Plastic Surgery · 22d
Cleared Sep 08, 1987
MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM
K873332 · GCY
American V. Mueller
General & Plastic Surgery · 20d
Cleared Sep 08, 1987
RAPID ELECTROPHORESIS SYSTEM (REP)
K873352 · JJN
Helena Laboratories
Chemistry · 19d
Cleared Sep 08, 1987
GAMMA GLUTAMYLTRANSFERASE
K873378 · JQB
Catachem, Inc.
Chemistry · 15d
Cleared Sep 08, 1987
MODEL 690 SPECTROPHOTOMETER
K873408 · JJQ
Abbott Diagnostics
Chemistry · 14d
Cleared Sep 08, 1987
TEMPLATE
K873470 · FTY
Cox-Uphuff Intl.
General & Plastic Surgery · 11d
Cleared Sep 04, 1987
LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)
K863135 · GXZ
Neurotechnics, Inc.
Neurology · 385d
Cleared Sep 04, 1987
HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)
K863136 · GXZ
Neurotechnics, Inc.
Neurology · 385d
Cleared Sep 04, 1987
MULTIPLE
K863387 · DXK
Del Mar Avionics
Cardiovascular · 366d
Cleared Sep 04, 1987
FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
K870801 · FRN
Travenol Laboratories, S.A.
General Hospital · 189d
Cleared Sep 04, 1987
MODEL K210 AND K211 FLUIDOTHERAPY UNITS
K871802 · LSB
Henley Intl.
Physical Medicine · 119d
Cleared Sep 04, 1987
JMS NEEDLES AND JMS SYRINGES
K871965 · FMF
Jms Co., Ltd.
General Hospital · 108d