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
104545–104568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1995
SYMBIOSIS BIPOLAR SCISSORS
K950286 · GCJ
Symbiosis Corp.
General & Plastic Surgery · 10d
Cleared Feb 02, 1995
BONE MULCH SCREW
K941941 · HWC
Biomet, Inc.
Orthopedic · 287d
Cleared Feb 02, 1995
SMT-50CX/H
K942669 · LNH
Shimadzu Medical Systems
Radiology · 241d
Cleared Feb 02, 1995
CIVCO PROBE BOOT/CORD COVER
K943393 · KKX
CIVCO Medical Instruments Co., Inc.
General Hospital · 203d
Cleared Feb 02, 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)
K944068 · DZE
Lifecore Biomedical, Inc.
Dental · 171d
Cleared Feb 02, 1995
JARIT RECOMMENDED SINUS INSTRUMENTS
K944670 · EOB
J. Jamner Surgical Instruments, Inc.
Ear, Nose, Throat · 133d
Cleared Feb 02, 1995
VOYAGER 522
K945032 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 112d
Cleared Feb 02, 1995
PARAPOST CEMENT
K945366 · EMA
Coltene/Whaledent, Inc.
Dental · 104d
Cleared Feb 02, 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569 · JSO
Becton Dickinson Microbiology Systems
Microbiology · 114d
Cleared Feb 02, 1995
EXCEL-P FORMULA AUTO-CURE DENTURE BASE
K945711 · EBI
St. George Technology, Inc.
Dental · 73d
Cleared Feb 02, 1995
3M X-LARGE SHEET #7979/ #7979NS
K946025 · KKX
3M Healthcare
General Hospital · 55d
Cleared Feb 02, 1995
PROTEMP(R) GARANT
K950203 · EBG
Espe GmbH & Co. Kg.
Dental · 15d
Cleared Feb 01, 1995
RADIUS ENTERAL FEEDING TUBE
K930510 · BSS
Radius Intl., Inc.
Gastroenterology & Urology · 730d
Cleared Feb 01, 1995
AME UNIVERSAL FIXATION SYSTEM
K931381 · KWP
American Medical Electronics, Inc.
Orthopedic · 685d
Cleared Feb 01, 1995
MODEL PDEXA BONE DENSITOMETER
K931996 · KGI
Norland Corp.
Radiology · 649d
Cleared Feb 01, 1995
ELDOR NEEDLE
K935255 · BSP
Csen , Ltd.
Anesthesiology · 457d
Cleared Feb 01, 1995
SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION
K940555 · LZH
Sandoz Nutrition
General Hospital · 359d
Cleared Feb 01, 1995
PACSPRO I
K940859 · LMD
Advanced Video Products, Inc.
Radiology · 343d
Cleared Feb 01, 1995
KNEE PROTHESIS
K941769 · JWH
Joint Medical Products Corp.
Orthopedic · 296d
Cleared Feb 01, 1995
MODEL FP-100
K942019 · JAA
International Medical Designs, Inc.
Radiology · 281d
Cleared Feb 01, 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · GKP
American Bioproducts Co.
Hematology · 274d
Cleared Feb 01, 1995
STRATO MEDICAL LIFEPORT LPS 7515
K942848 · LJT
Strato Medical Corp.
General Hospital · 230d
Cleared Feb 01, 1995
SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
K943113 · IYO
Aloka Co., Ltd.
Radiology · 219d
Cleared Feb 01, 1995
ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE
K943426 · HRX
Schoelly Technologies, Inc.
Orthopedic · 201d