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
127153–127176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1990
SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY
K896762 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 77d
Cleared Feb 16, 1990
DISPOSABLE URODYNAMIC CATHETER SET
K896784 · KOD
Life-Tech Intl., Inc.
Gastroenterology & Urology · 74d
Cleared Feb 16, 1990
SUCTION CATHETER KIT
K896797 · BSY
Westmark, Sterile Packing Systems,...
Anesthesiology · 77d
Cleared Feb 16, 1990
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
K896845 · CDL
Reagents Applications, Inc.
Chemistry · 72d
Cleared Feb 16, 1990
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
K896935 · FYA
Baxter Healthcare Corp
General Hospital · 65d
Cleared Feb 16, 1990
MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
K896949 · EAK
Innovative Products Mfg.
Radiology · 65d
Cleared Feb 16, 1990
PORT INFUSION SET (PIS) INFUSION SET (IS)
K897065 · FPA
Prn Services, Inc.
General Hospital · 58d
Cleared Feb 16, 1990
MODEL 2800 ND:YAG OPHTHALMIC LASER
K897099 · GEX
Alcon Surgical, Inc.
General & Plastic Surgery · 57d
Cleared Feb 16, 1990
MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)
K900063 · GWL
Bio-Feedback Systems, Inc.
Neurology · 44d
Cleared Feb 16, 1990
MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM
K900070 · HRX
Dyonics, Inc.
Orthopedic · 43d
Cleared Feb 16, 1990
BIO FLOTE(R)
K900131 · FNM
Bio Clinic Co.
General Hospital · 37d
Cleared Feb 16, 1990
A-SCAN ROLL-AROUND STAND
K900161 · HMG
Jedmed Instrument Co.
Ophthalmic · 35d
Cleared Feb 16, 1990
DGH A-SAN PROBE HOLDER
K900162 · HDR
Jedmed Instrument Co.
Obstetrics & Gynecology · 35d
Cleared Feb 16, 1990
CENTRIPREP 100
K900280 · JJP
Amicon, Inc.
Chemistry · 29d
Cleared Feb 16, 1990
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN
K900448 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 24d
Cleared Feb 15, 1990
VITACHOICE WOUND DRESSING
K896455 · KGX
Vitaphore Corp.
General & Plastic Surgery · 98d
Cleared Feb 15, 1990
ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM))
K896542 · JWH
Techmedica, Inc.
Orthopedic · 90d
Cleared Feb 15, 1990
ULTRAMARK 7 ULTRASOUND SYSTEM
K896543 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 90d
Cleared Feb 15, 1990
STORZ FIBEROPTIC ENDO-ILLUMINATORS
K896549 · HBI
Storz Instrument Co.
General & Plastic Surgery · 90d
Cleared Feb 15, 1990
GOOSEN URINARY DRAINAGE SYSTEM
K896579 · KNX
Goosen Enterprises, Inc.
Gastroenterology & Urology · 87d
Cleared Feb 15, 1990
UNI-POLAR HEAD
K896580 · LZY
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared Feb 15, 1990
RMI ANTEPLEGIA CANNULA
K896636 · DWF
Research Medical, Inc.
Cardiovascular · 85d
Cleared Feb 15, 1990
K-SPONGE
K897034 · HOZ
Katena Products, Inc.
Ophthalmic · 59d
Cleared Feb 15, 1990
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · JOJ
Edward Weck, Inc.
General Hospital · 58d