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
130297–130320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1989
NASOGASTRIC PH SUCTION CATHETER, ST-5001
K891410 · FFT
Sensatronix Medical Systems, Inc.
Gastroenterology & Urology · 101d
Cleared Jun 23, 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · JXG
Baxter Healthcare Corp
Neurology · 100d
Cleared Jun 23, 1989
MAGNAVIEW MOBILE MRI VERSION 110 FHM
K891543 · LNH
Instrumentarium Imaging, Inc.
Radiology · 98d
Cleared Jun 23, 1989
MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED
K891760 · LNH
Bruker Medical Imaging, Inc.
Radiology · 92d
Cleared Jun 23, 1989
VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED
K891771 · CAN
Thermadyne Holings Corp.
Anesthesiology · 91d
Cleared Jun 23, 1989
PS3500 ARTHROSCOPIC SURGICAL SYSTEM
K892062 · HRX
Dyonics, Inc.
Orthopedic · 85d
Cleared Jun 23, 1989
GENTLEHALER(R)
K892117 · CCQ
Schering Research
Anesthesiology · 84d
Cleared Jun 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892266 · LYY
Jenn Jiag Ent. Co., Ltd. C/O Rosyn...
General Hospital · 79d
Cleared Jun 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892289 · LYY
Ansell, Inc.
General Hospital · 78d
Cleared Jun 23, 1989
KALTOSTAT(TM) WOUND DRESSING
K892364 · FRO
Calgon Vestal Div.
General & Plastic Surgery · 78d
Cleared Jun 23, 1989
SPIN-CLEAN CLEANING UNIT
K892372 · LYL
Willmar Contact Lens Co.
Ophthalmic · 78d
Cleared Jun 23, 1989
NSD 8CS8 - TENS DEVICE
K892408 · GZJ
Future Medical Products, Inc.
Neurology · 77d
Cleared Jun 23, 1989
KENDALL KENGUARD URINARY LEG BAGS
K892437 · KNX
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
KENDALL CURITY STOMACH TUBES
K892439 · KNT
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
KENDALL CURITY URETHRAL CATHETERS
K892442 · GBM
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892566 · LYY
Foodhandler, Inc.
General Hospital · 74d
Cleared Jun 23, 1989
SENSIMAT
K892657 · IZO
Transworld X-Ray Corp.
Radiology · 71d
Cleared Jun 23, 1989
CATHETERS, MALE, FEMALE
K892691 · KOD
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 23, 1989
THE STAGO VIII DEFICIENT PLASMA KIT
K892859 · GGP
American Bioproducts Co.
Hematology · 66d
Cleared Jun 23, 1989
SATURNE 41
K892860 · IYE
General Electric Co.
Radiology · 66d
Cleared Jun 23, 1989
DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101
K892881 · EHZ
Nieusma R & D, Inc.
Dental · 78d
Cleared Jun 23, 1989
DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102
K892882 · EHZ
Nieusma R & D, Inc.
Dental · 78d
Cleared Jun 23, 1989
BREATH TRACKER
K892942 · CAP
Core-M, Inc.
Anesthesiology · 63d
Cleared Jun 23, 1989
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
K893140 · JJX
Casco Standards
Chemistry · 59d