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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
102337–102360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1995
DESRA
K945820 · LQZ
D.S.R.A., Inc.
Dental · 199d
Cleared Jun 15, 1995
ACTIC 2002
K946169 · BXB
North Atlantic Rehabilitation, Inc.
Physical Medicine · 178d
Cleared Jun 15, 1995
VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE...
K946271 · GAM
Ethicon, Inc.
General & Plastic Surgery · 174d
Cleared Jun 15, 1995
CITATION POWER TOOL
K946290 · HRX
Citation Medical Corp.
Orthopedic · 170d
Cleared Jun 15, 1995
ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE
K950215 · GEX
Reliant Laser Corp.
General & Plastic Surgery · 147d
Cleared Jun 15, 1995
ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K950418 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 135d
Cleared Jun 15, 1995
NEITZ SLIT LAMP SL-H2
K951341 · HJO
Neitz Instruments Company, Ltd.
Ophthalmic · 83d
Cleared Jun 15, 1995
STANDARD FOLEY SYSTEM PAK
K951443 · FCN
Trinity Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 15, 1995
AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
K951462 · HQC
Allergan Medical Optics
Ophthalmic · 77d
Cleared Jun 15, 1995
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
K951479 · FCM
Trinity Laboratories, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 15, 1995
T-UPTAKE CALIBRATORS
K951585 · JIS
Diagnostic Reagents, Inc.
Chemistry · 70d
Cleared Jun 15, 1995
DISPOSABLE LATEX PATIENT EXAMINATION GLOVES
K951670 · LYY
Emi Groups (U.S.A.), Inc.
General Hospital · 65d
Cleared Jun 15, 1995
ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES
K951839 · LYY
Aladan Corp.
General Hospital · 56d
Cleared Jun 15, 1995
ACCESS EXPANSION SYSTEM
K951894 · FHO
Micro-Medical Devices, Inc.
Gastroenterology & Urology · 52d
Cleared Jun 15, 1995
CARDON PHYSICAL THERAPY TABLES MODELS R28591 & R28592
K951906 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 52d
Cleared Jun 15, 1995
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
K952149 · LQR
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 38d
Cleared Jun 15, 1995
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573 · FEN
Rusch Intl.
Gastroenterology & Urology · 10d
Cleared Jun 14, 1995
ROGOZINSKI SPINAL ROD SYSTEM SCREW
K930298 · MNH
Smith & Nephew Richards, Inc.
Orthopedic · 874d
Cleared Jun 14, 1995
MULTI-DOP X
K931801 · IYO
Dantec Medical, Inc.
Radiology · 867d
Cleared Jun 14, 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590 · HWC
Smith & Nephew Richards, Inc.
Orthopedic · 628d
Cleared Jun 14, 1995
ITI ANGLED ABUTMENT
K941393 · DZE
The Straumann Co.
Dental · 449d
Cleared Jun 14, 1995
HCI TUBE STABILIZER
K942529 · CBH
Health Care Contracts, Inc.
Anesthesiology · 383d
Cleared Jun 14, 1995
SMARTFLOW I ADMINISTRATION SET
K945298 · FPA
River Medical, Inc.
General Hospital · 226d
Cleared Jun 14, 1995
POC ARTHROSCOPE AND ACCESSORIES
K945684 · HRX
Precision Optics Corp.
Orthopedic · 205d