FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
129409–129432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
K895260 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
K895261 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262 · GIZ
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
INTRAVENOUS EXTENSION SET
K895367 · FPA
Medical Product Specialists
General Hospital · 39d
Cleared Oct 06, 1989
HEMATOLOGY CONTROL
K895373 · JCN
Medical Specialties Intl., Inc.
Hematology · 38d
Cleared Oct 06, 1989
UNDER BUTTOCKS DRAPE
K895404 · KKX
Medical Plastics, Inc.
General Hospital · 29d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-VIII
K895503 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 24d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-IX
K895504 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 24d
Cleared Oct 06, 1989
THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM
K895527 · FSM
Quantitative Technologies, Inc.
General & Plastic Surgery · 24d
Cleared Oct 06, 1989
ROCKET BONE MARROW NEEDLE
K895551 · GDM
A & A Medical, Inc.
General & Plastic Surgery · 23d
Cleared Oct 06, 1989
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
K895594 · GDM
Go Medical Industries Pty. , Ltd.
General & Plastic Surgery · 21d
Cleared Oct 06, 1989
S.S.T. SURGICAL THIMBLE
K895603 · KGO
Healthcare Technologies Resources, Inc.
General Hospital · 18d
Cleared Oct 05, 1989
ATTENUATING SURGICAL GLOVE
K891315 · LZC
F & L Medical Products Co.
General Hospital · 206d
Cleared Oct 05, 1989
SONOLINE CF
K891449 · IYO
Siemens Ultrasound, Inc.
Radiology · 204d
Cleared Oct 05, 1989
THE ORIGINAL PULSE-PAK
K892639 · NFB
Jones Sales Co.
Anesthesiology · 176d
Cleared Oct 05, 1989
BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR
K892841 · CCJ
Bedfont Technical Instruments , Ltd.
Anesthesiology · 170d
Cleared Oct 05, 1989
EXTACISER PERINEAL MUSCLE EXERCISER
K892888 · HIR
Bivona Medical Technologies
Gastroenterology & Urology · 168d
Cleared Oct 05, 1989
MODEL 285 INFUSION PUMP
K894321 · FRN
3M Company
General Hospital · 83d
Cleared Oct 05, 1989
LIFECARE PRESSURE ALARM CAT. NO. 34-010
K894361 · CAP
Lifecare Services, Inc.
Anesthesiology · 83d
Cleared Oct 05, 1989
LATEX PATIENT EXAMINATION GLOVES
K894453 · LYY
Mittal Meditex Pvt. , Ltd.
General Hospital · 107d
Cleared Oct 05, 1989
GYNECOLOGIC EXAMINATION KIT
K894489 · HIB
A & A Medical, Inc.
Obstetrics & Gynecology · 77d
Cleared Oct 05, 1989
STERILE ULTRASOUND TRANSMISSION GEL
K894490 · JOT
Swedish Trade Council USA
General & Plastic Surgery · 79d
Cleared Oct 05, 1989
SIEMENS ENDO-P-PROBE
K894806 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Oct 05, 1989
IRIS OCULIGHT(TM) SL
K894841 · GEX
Iriderm Div.
General & Plastic Surgery · 66d