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
131137–131160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1989
VITALOGRAPH-BREATHCO MONITOR
K892524 · CCJ
Vitalograph , Ltd.
Anesthesiology · 24d
Cleared May 05, 1989
NEUROSURGICAL DRILLS: STILLE, HUDSON
K892531 · HBG
Zinnanti Surgical Instruments, Inc.
Neurology · 24d
Cleared May 05, 1989
NEUROSURICAL RETRACTORS - VARIOUS TYPES
K892543 · GZT
Zinnanti Surgical Instruments, Inc.
Neurology · 24d
Cleared May 04, 1989
SELECTIVE RAPID UREA
K883641 · LYR
Remel Co.
Microbiology · 252d
Cleared May 04, 1989
ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS
K884267 · CHL
Alko Diagnostic Corp.
Chemistry · 205d
Cleared May 04, 1989
PERME-AID TRANSPARENT DRESSING, #11XX
K884791 · NAD
Nitto Denko Technical Corp.
General & Plastic Surgery · 170d
Cleared May 04, 1989
SURG-E-TROL SYSTEM I AND SYSTEM II
K890622 · HQE
Mentor O & O, Inc.
Ophthalmic · 86d
Cleared May 04, 1989
AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
K890818 · FZT
United States Surgical, A Division of...
General & Plastic Surgery · 76d
Cleared May 04, 1989
PATIENT EXAMINATION GLOVES
K890872 · LYY
Unigloves , Ltd.
General Hospital · 69d
Cleared May 04, 1989
VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX)
K890967 · LYZ
Amerimed US Corp.
General Hospital · 66d
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