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
128065–128088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1989
BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG.
K895816 · DIF
Bio-Rad
Toxicology · 69d
Cleared Dec 06, 1989
MODEL 600 SYRINGE PUMP
K891237 · FRN
3M Company
General Hospital · 274d
Cleared Dec 06, 1989
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646 · FPA
Baxter Healthcare Corp
General Hospital · 205d
Cleared Dec 06, 1989
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
K894778 · HBO
Codman & Shurtleff, Inc.
Neurology · 132d
Cleared Dec 06, 1989
A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT
K896093 · LJT
Therex Corp.
General Hospital · 48d
Cleared Dec 06, 1989
COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
K896156 · GZT
Stereotactic Medical Systems, Inc.
Neurology · 43d
Cleared Dec 06, 1989
DISPOSABLE EXTERNAL CLAMPS
K896383 · GDI
Galenica Enterprises, Inc.
General & Plastic Surgery · 30d
Cleared Dec 06, 1989
DISPOSABLE 45 DEGREE SHAVER
K896538 · HRX
Bowen & Company, Inc.
Orthopedic · 20d
Cleared Dec 06, 1989
EXACTECH BONE SCREW
K896601 · HWC
Exactech, Inc.
Orthopedic · 15d
Cleared Dec 05, 1989
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
K891121 · DYB
Boston Scientific Corp
Cardiovascular · 278d
Cleared Dec 05, 1989
TRU-TOUCH VINYL, NON-STERILE
K891719 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 259d
Cleared Dec 05, 1989
TAGUM LATEX EXAMINATION GLOVES
K892073 · LYY
Tagum Rubber Industries, Ltd.
General Hospital · 246d
Cleared Dec 05, 1989
TRU-TOUCH VINYL, STERILE
K892327 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 259d
Cleared Dec 05, 1989
FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES
K892328 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 259d
Cleared Dec 05, 1989
DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS
K892926 · LJS
Vas-Cath, Inc.
General Hospital · 228d
Cleared Dec 05, 1989
LATEX EXAMINATION GLOVES
K893357 · LYY
M.M. Rubber Co. , Ltd.
General Hospital · 225d
Cleared Dec 05, 1989
ECG SIMULATOR MODEL ECGPLUS
K893660 · DPS
Bio-Tek Instruments, Inc.
Cardiovascular · 204d
Cleared Dec 05, 1989
PATIENT EXAMINATION GLOVES
K894308 · LYY
Xing Huao Co. , Ltd.
General Hospital · 165d
Cleared Dec 05, 1989
IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
K894748 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d
Cleared Dec 05, 1989
LATEX EXAMINATION GLOVES
K895322 · LYY
Advantage Resources
General Hospital · 98d
Cleared Dec 05, 1989
LATEX PATIENT EXAMINATION GLOVES
K895642 · OPE
Siam Sempermed Corp., Ltd.
General & Plastic Surgery · 77d
Cleared Dec 05, 1989
IMPEDANCE ANALYZER MODELS MD-2, MD-P
K895783 · ETY
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d
Cleared Dec 05, 1989
IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
K895784 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d
Cleared Dec 05, 1989
AUDIOMETER MODEL MD-4, MD-4P
K895785 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 132d