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
131737–131760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES
K891012 · LYY
Semodal Jaya Sdn. Bhd.
General Hospital · 65d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891127 · LYY
Sppik Rubber Industries Sdn. Bhd.
General Hospital · 62d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES
K891194 · LYY
Star Light Ent. Corp.
General Hospital · 59d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891274 · LYY
Yue Chuen Co., Ltd.
General Hospital · 56d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES
K891313 · LYY
Dr. Boo Co., Ltd.
General Hospital · 55d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891427 · LYY
Shinheng Corp.
General Hospital · 51d
Cleared May 04, 1989
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
K891696 · NAD
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 43d
Cleared May 04, 1989
PRO-CUT BIOPSY NEEDLE
K891777 · FCG
Teknar, Inc.
Gastroenterology & Urology · 41d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891851 · LYY
Klh Medical, Inc.
General Hospital · 38d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892086 · LYY
Cypress Medical Products, Ltd.
General Hospital · 31d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892109 · LYY
Brilliant Ray Intl., Inc.
General Hospital · 31d
Cleared May 04, 1989
BEHRING NEPHELOMETER 100
K892223 · JZW
Behring Diagnostics, Inc.
Immunology · 31d
Cleared May 04, 1989
BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET
K892383 · FGE
Porges Corp.
Gastroenterology & Urology · 28d
Cleared May 04, 1989
BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
K892384 · FGE
Porges Corp.
Gastroenterology & Urology · 28d
Cleared May 04, 1989
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN
K892409 · DHB
Quidel Corp.
Immunology · 27d
Cleared May 04, 1989
S-100 ALLEN-BROWN SHUNT
K892663 · FIQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 21d
Cleared May 04, 1989
SAF-T-SHUNT, S-300 SERIES
K892666 · FIQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 21d
Cleared May 04, 1989
SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313
K892667 · FKN
Akcess Medical Products, Inc.
Gastroenterology & Urology · 21d
Cleared May 03, 1989
ACROMED ILIAC SCREW
K884161 · KWP
Buckman Co., Inc.
Orthopedic · 211d
Cleared May 03, 1989
TOTAL CHOLESTEROL REAGENT
K890334 · CHH
Alpkem Corp.
Chemistry · 100d
Cleared May 03, 1989
LABSONICS MAMM-O-MATE MODEL NO. 918084-1
K890519 · IYO
Laboratory Equipment Corp.
Radiology · 90d
Cleared May 03, 1989
MAMMOMAT C
K890784 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 03, 1989
POTASSIUM AND SODIUM ELECTROLYTE ANALYZER
K890792 · CEM
Ionetics, Inc.
Chemistry · 75d
Cleared May 03, 1989
GENERAL ELECTRIC AMX 110
K891143 · IZL
Pro-Tronics, Inc.
Radiology · 61d