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
135817–135840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1988
LINDER NASOTRACHEAL AIRWAY
K881496 · BTR
Polamedco, Inc.
Anesthesiology · 53d
Cleared May 31, 1988
MODIFIED SERVO SYRINGE
K881521 · DXT
Engineering, Inc.
Cardiovascular · 53d
Cleared May 31, 1988
EPICARDIA LE/FD
K881770 · DQK
Medicomp, Inc.
Cardiovascular · 35d
Cleared May 31, 1988
N.S. CADEE
K881785 · FMI
First Scientific, Div.
General Hospital · 35d
Cleared May 31, 1988
UVMAX KINETIC MICROPLATE READER
K881803 · JJQ
Molecular Devices Corp.
Chemistry · 33d
Cleared May 31, 1988
MSI 5000 SERIES BED
K881965 · FNL
Med Service, Inc.
General Hospital · 21d
Cleared May 31, 1988
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · IXR
General Electric Co.
Radiology · 18d
Cleared May 27, 1988
LIPASE UV [TOYO]
K874027 · CHI
Advocacy International, Ltd.
Chemistry · 238d
Cleared May 27, 1988
ABBOTT BREATH ACETONE ANALYZER
K875029 · JIN
Abbott Laboratories
Chemistry · 172d
Cleared May 27, 1988
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
K875181
Marion Laboratories, Inc.
Toxicology · 162d
Cleared May 27, 1988
DART PHENYTOIN
K880294 · LFO
Coulter Electronics, Inc.
Chemistry · 123d
Cleared May 27, 1988
CALCIUM
K880308 · CIC
Catachem, Inc.
Chemistry · 123d
Cleared May 27, 1988
MULTI-FUNCTION BLOOD GAS CONTROL
K880447 · JJY
Bionostics, Inc.
Chemistry · 115d
Cleared May 27, 1988
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
K880692 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 95d
Cleared May 27, 1988
LIQUID CHROMATO. COLUMNS
K880724 · DPM
Supelco, Inc.
Toxicology · 95d
Cleared May 27, 1988
GDS ENZYMATIC ACETAMINOPHEN REAGENT
K880829 · LDP
Gds Technology, LLC
Toxicology · 87d
Cleared May 27, 1988
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC
K880880 · JGJ
Reagents Applications, Inc.
Chemistry · 86d
Cleared May 27, 1988
LYTENING 5
K880917 · JGS
Amdev, Inc.
Chemistry · 85d
Cleared May 27, 1988
IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
K881005 · JHI
Icn Biomedicals, Inc.
Chemistry · 79d
Cleared May 27, 1988
IMMPULSE T, ASSAY REAGENTS
K881214 · CDP
Sclavo, Inc.
Toxicology · 67d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229 · JJY
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared May 27, 1988
TOTAL BILIRUBIN REAGENT
K881241 · CIG
Tech-Neal Scientific, Inc.
Chemistry · 66d
Cleared May 27, 1988
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257 · KLS
Immunotech Corp.
Toxicology · 65d
Cleared May 27, 1988
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258 · JIX
Baxter Healthcare Corp
Toxicology · 65d