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
172489–172512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1978
TOTAL HIP SYSTEM, HARRIS HD2
K780317 · JDI
Howmedica Corp.
Orthopedic · 10d
Cleared Mar 03, 1978
AUTOZYME GLUCOSE OXIDASE (TRINDER)
K772308 · CGA
J.T. Baker Chemical Co.
Chemistry · 77d
Cleared Mar 03, 1978
LDH ISOENZYME CONTROL SERUM
K780096 · JJY
Worthington Biochemical Corp.
Chemistry · 44d
Cleared Mar 03, 1978
CSF TOTAL PROTEIN TEST SET #0340
K780110 · JGQ
Stanbio Laboratory
Chemistry · 43d
Cleared Mar 03, 1978
RIA FOR FOLATES & VIT. B12, COMBO KIT
K780148 · CGN
Ria Products, Inc.
Chemistry · 32d
Cleared Mar 03, 1978
CHEMISTRY CONTROL & REFERENCE SERUMS
K780204 · JJT
Hyland Therapeutic Div., Travenol...
Chemistry · 24d
Cleared Mar 03, 1978
ASPIRATOR, MANUEL
K780208 · JQW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 24d
Cleared Mar 03, 1978
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE
K780218 · DIP
Syva Co.
Toxicology · 21d
Cleared Mar 03, 1978
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY
K780219 · CDX
Syva Co.
Chemistry · 21d
Cleared Mar 02, 1978
HEAT EXCHANGER, DISP., OMNITHERM
K772117 · DTR
Scimed Life Systems, Inc.
Cardiovascular · 114d
Cleared Mar 02, 1978
BLADDER RETENTION-CATHETHERIZATIONTRAY
K772277 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 83d
Cleared Mar 02, 1978
SEXUAL ASSAULT FORENCIC EVIDENCE KIT
K772298 · KXF
Simpson/Basye, Inc.
General Hospital · 79d
Cleared Mar 02, 1978
PLATELET AGGREGATING REAGENTS
K780047 · JOZ
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 52d
Cleared Mar 02, 1978
LIQUID OXYGEN UNIT, PORTABLE 73BYJ
K780098 · BYJ
Andonian Cryogenics, Inc.
Anesthesiology · 42d
Cleared Mar 02, 1978
DILATOR, VESSEL & INTRODUCER, SHEATH
K780126 · DRE
Argon Medical Corp.
Cardiovascular · 37d
Cleared Mar 02, 1978
DUAL CHANNEL PULSE HEIGHT ANALYZER
K780155 · IYX
Iso Graphics, Inc.
Radiology · 31d
Cleared Mar 02, 1978
PROCESSOR, VIDEO IMAGE VIP-550
K780165 · IYX
Ohio Nuclear, Inc.
Radiology · 30d
Cleared Mar 02, 1978
DISPLAY SYSTEM MODEL 428
K780176 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 27d
Cleared Mar 02, 1978
FETAL MONITOR MODEL 112
K780177 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 27d
Cleared Mar 02, 1978
NEUROMOD STIMULATOR MODEL 3723
K780186 · GZJ
Medtronic Vascular
Neurology · 24d
Cleared Mar 02, 1978
ULTRASCOPE
K780200 · JAF
L&M Ultrascope Life Monitoring Sys.
Radiology · 22d
Cleared Mar 02, 1978
SPEAKER-AMPLIFIER & RECORDER INTERFACE
K780201 · JAF
L&M Ultrascope Life Monitoring Sys.
Radiology · 22d
Cleared Mar 02, 1978
ABDOMINAL BELT
K780229 · KTD
Biomet, Inc.
Physical Medicine · 21d
Cleared Mar 02, 1978
TAMPON, RELY MODIFIED
K780243 · HEB
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 17d