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
129409–129432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 29, 1989
LATEX EXAMINATION GLOVES
K894324 · LYY
M/S Overseas Latex Pvt. , Ltd.
General Hospital · 46d
Cleared Aug 29, 1989
LATEX PATIENT EXAMINATION GLOVES
K894773 · LYY
Transrich Industries Sdn. Bhd.
General Hospital · 34d
Cleared Aug 29, 1989
DMI 250 SERIES POWER SURGERY TABLE
K894789 · JEA
M.D. Intl., Inc.
General & Plastic Surgery · 32d
Cleared Aug 28, 1989
DANEK WRIST FIXATOR
K891066 · KTT
Danek Medical, Inc.
Orthopedic · 180d
Cleared Aug 28, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892047 · LYY
Gainlite Co., Ltd.
General Hospital · 150d
Cleared Aug 28, 1989
MULTI-DRUG(TM) INFUSION SYSTEM
K892210 · FRN
I-Flow Corp.
General Hospital · 147d
Cleared Aug 28, 1989
RCI VIRAL/BACTERIAL FILTER
K892230 · CAH
Respiratory Care, Inc.
General Hospital · 146d
Cleared Aug 28, 1989
DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM
K892370 · DXH
Bio-Focus, Inc.
Cardiovascular · 144d
Cleared Aug 28, 1989
TOMAX ULTRASCAN
K892653 · IZF
Incubation Industries, Inc.
Radiology · 137d
Cleared Aug 28, 1989
STATSPIN MINI-PLASMA
K893613 · JKA
Statspin Technologies
Chemistry · 110d
Cleared Aug 28, 1989
HOBBS MEDICAL MICROBIOLOGY BRUSH
K893729 · FDX
Hobbs Medical, Inc.
Gastroenterology & Urology · 103d
Cleared Aug 28, 1989
COUGH PILLOW
K893809 · KMO
Custom Hospitals Products
General Hospital · 98d
Cleared Aug 28, 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 28, 1989
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
K893917 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 90d