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
129385–129408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES
K892963 · LYY
Mao Gang Industrial Co.
General Hospital · 141d
Cleared Aug 31, 1989
LATEX NON-STERILE PATIENT EXAMINATION GLOVES
K892973 · LYY
Polikon Trading Co.
General Hospital · 141d
Cleared Aug 31, 1989
LATEX EXAMINATION GLOVES
K893450 · LYY
Ken FA Latex Products Corp.
General Hospital · 120d
Cleared Aug 31, 1989
EMDS CREATINE KINASE ITEM NIMBER 65411
K893691 · CGS
Diagnostic Systems
Chemistry · 107d
Cleared Aug 31, 1989
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
K893838 · JQP
Ciba Corning Diagnostics Corp.
Chemistry · 99d
Cleared Aug 31, 1989
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K894022 · LYY
Baxter Healthcare Corp
General Hospital · 86d
Cleared Aug 31, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K894023 · LYZ
Baxter Healthcare Corp
General Hospital · 86d
Cleared Aug 31, 1989
EVAC-TUBE
K894032 · CAO
Sharn, Inc.
Anesthesiology · 86d
Cleared Aug 31, 1989
QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
K894057 · LBS
Photec Diagnostics, Inc.
Chemistry · 85d
Cleared Aug 31, 1989
ROCHO ISOMUNE - LD
K894081 · CFE
Roche Diagnostic Systems, Inc.
Chemistry · 84d
Cleared Aug 31, 1989
POSITIVE AND NEGATIVE HCG URINE CONTROLS
K894181 · JJX
Armkel, LLC
Chemistry · 76d
Cleared Aug 31, 1989
HYPAFIX DRESSING RETENTION SHEET
K894254 · NAD
Smith & Nephew United, Inc.
General & Plastic Surgery · 72d
Cleared Aug 31, 1989
PHOSPHORUS TEST ITEM NUMBER 65416
K894288 · CED
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Aug 31, 1989
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
K894366 · LBT
Helena Laboratories
Chemistry · 48d
Cleared Aug 31, 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Aug 31, 1989
MAGNESIUM TEST ITEM NUMBER: 65419
K894508 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Aug 31, 1989
DYNATECH MR 5000, CATALOG #011-976-0600
K894687 · JJQ
Dynatech Laboratories, Inc.
Microbiology · 37d
Cleared Aug 31, 1989
DPC-ROBOSTAT(TM)
K894710 · JQW
Diagnostic Products Corp.
Chemistry · 38d
Cleared Aug 31, 1989
SENSITITRE INDOLE REAGENT
K894776 · JSS
Radiometer America, Inc.
Microbiology · 35d
Cleared Aug 31, 1989
8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI
K894850 · CAN
Modern Engineering Co., Inc.
Anesthesiology · 31d
Cleared Aug 30, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891504 · LYY
Lon Tai Chemical Industrial Co., Ltd.
General Hospital · 167d
Cleared Aug 30, 1989
PATIENT EXAMINATION GLOVES
K893085 · LYY
Jiangsu Medicines & Health Products...
General Hospital · 139d
Cleared Aug 30, 1989
THE HANDSCAN SYSTEM
K893455 · KQX
Digital Body Systems, Inc.
Neurology · 119d