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
129985–130008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 30, 1989
EB VCA STAT M TEST KIT
K894235 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 71d
Cleared Aug 30, 1989
BIOTROL RUB-E.I.A. TEST G
K894544 · LFX
Biotrol, USA, Inc.
Microbiology · 41d
Cleared Aug 30, 1989
CYPRESS CANNULATED BONE SCREW
K894830 · HWC
Cypress Medical Mfg., Inc.
Orthopedic · 30d
Cleared Aug 30, 1989
STAPLE FIXATION SYSTEM
K894929 · JDR
Concept, Inc.
Orthopedic · 28d
Cleared Aug 29, 1989
TIGER PATIENT EXAM GLOVES
K892978 · LYY
Daesung America Co., Inc.
General Hospital · 139d
Cleared Aug 29, 1989
HARCROS EXAMINATION GLOVES
K893823 · LYY
H&C Rubber Products Sdn. Bhd.
General Hospital · 98d
Cleared Aug 29, 1989
MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
K893911 · HBL
Medical Equipment Development Co., Inc.
Neurology · 91d
Cleared Aug 29, 1989
PATIENT EXAMINATION GLOVES
K894125 · LYY
Yaw Chang Enterprises Co., Ltd.
General Hospital · 78d
Cleared Aug 29, 1989
MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND
K894164 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 75d
Cleared Aug 29, 1989
PHYNE-TOUCH-STERILE
K894212 · LYY
Medical Resources, Ltd.
General Hospital · 71d