FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171649–171672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 02, 1978
CRONEX QC-1 PROCESSOR
K780248 · IXW
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 17d
Cleared Mar 02, 1978
COBE STOPCOCK
K780271 · DTL
Cobe Laboratories, Inc.
Cardiovascular · 13d
Cleared Mar 02, 1978
RADIATION THERAPY TREAT. PLAN. SYS.
K780278 · JAD
Pfizer Medical Systems, Inc.
Radiology · 13d
Cleared Mar 02, 1978
IMMUFUGE DISP. LINER
K780281 · KSO
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 9d
Cleared Mar 02, 1978
TRIA-PEG RIA DIAG. KIT
K780292 · CDP
Nuclear Diagnostics, Inc.
Toxicology · 9d
Cleared Feb 28, 1978
FLAME PHOTOMETER STANDARD
K772153 · JIT
Alko Scientific Co.
Chemistry · 105d