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

Filters: Cleared only ×
176,076 results
153337–153360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1984
EAR CURETTE, VARIOUS
K841001 · JYG
Premier Dental Products Co.
Ear, Nose, Throat · 81d
Cleared May 25, 1984
NEURO SECTOR FIXATION DEVICE
K833522 · GXW
Advanced Technology Laboratories, Inc.
Neurology · 249d
Cleared May 25, 1984
P-S MEDICAL CSF ACCESS DEV 15MM/25MM
K833822 · LKG
Pudenz-Schulte Medical Research Corp.
General Hospital · 205d
Cleared May 25, 1984
LITHOTRIPTOR ELECTRODE 4.5F
K834228 · FFK
Monaghan Medical Corp.
Gastroenterology & Urology · 171d
Cleared May 25, 1984
AMNIO STAT-FLM AGGLUTINATION TEST
K834616 · JHG
Hana Biologics, Inc.
Microbiology · 163d
Cleared May 25, 1984
SHEER ENERGY PANTY HOSE
K840335 · DWL
Leggs Products, Inc.
General Hospital · 121d
Cleared May 25, 1984
INFANT RADIANT WARMER
K840792 · FMT
Hatch Bio Medical
General Hospital · 92d
Cleared May 25, 1984
THROAT MOI-STIR
K840807 · LFD
Kingswood Laboratories, Inc.
Dental · 91d
Cleared May 25, 1984
ENDO-JECT
K840943 · BTR
Autovage
Anesthesiology · 81d
Cleared May 25, 1984
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
K841021 · JOX
Hemotec, Inc.
Hematology · 74d
Cleared May 25, 1984
SPORSTRIP
K841583 · FRC
Skyland Scientific Services, Inc.
General Hospital · 38d
Cleared May 25, 1984
COMPONENTS FOR PARTIAL PRESSURE ELEE
K841609 · CHL
Shaban Mfg. Co.
Chemistry · 46d
Cleared May 25, 1984
COMPONENTS FOR POTASSIUM, SODIUM CHLO
K841610 · JGT
Shaban Mfg. Co.
Chemistry · 46d
Cleared May 25, 1984
CODE-A-WELL SERIES 200 PLATE
K841632 · LIB
Plastic Injectors, Inc.
Microbiology · 35d
Cleared May 25, 1984
SELECTIVE CULTURE MED. SELECTIVE STREP
K841839 · JSJ
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
SELECTIVE CULTURE MED. PHENYLETHYL ALCO
K841840 · JSJ
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
DIFFERENTIAL CULTURE MED. MANNITOL SALT
K841841 · JSI
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
DSL FERRITIN IRMA
K841925 · DBF
Diagnostic Systems Laboratories, Inc.
Immunology · 15d
Cleared May 25, 1984
MARQUEST MICRO STIK 9000 SERIES
K842008 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 8d
Cleared May 23, 1984
BIOMER * PLEDGET SUTURE BUTTRESS
K832138 · KGS
Ethicon, Inc.
General & Plastic Surgery · 327d
Cleared May 23, 1984
ESOPHOGRAL MULTIPROBE
K832903 · DRX
Vital Signs, Inc.
Cardiovascular · 268d
Cleared May 23, 1984
CIRCULATOR MINIBOOT
K833627 · DRN
Circulator Boot Corp.
Cardiovascular · 222d
Cleared May 23, 1984
ANGIOSCANE SPECTRUM ANALYZER
K834501
Unigon Industries, Inc.
Neurology · 154d
Cleared May 23, 1984
ANGIOSCAN FLO MAD SPECTRUM ANALYZER
K834525 · JOP
Unigon Industries, Inc.
Cardiovascular · 154d