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
105337–105360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1994
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL
K945315 · JJY
Casco Standards
Chemistry · 38d
Cleared Dec 09, 1994
CLARIT(TM)
K945353 · JKA
Advanced Biomedical Methods, Inc.
Chemistry · 50d
Cleared Dec 09, 1994
COMPAS
K945483 · IZI
General Electric Co.
Radiology · 31d
Cleared Dec 09, 1994
H 5100, H 5200, H 5300
K945507 · KZF
Rudolf Riester GmbH & Co. KG
General Hospital · 30d
Cleared Dec 09, 1994
BIOPSY DEVICE ACCESSORY
K945573 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 25d
Cleared Dec 08, 1994
SLIP-COAT STENTS
K930731 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 665d
Cleared Dec 08, 1994
PHILIPS ULTRASOUND P800 IMAGING SYSTEM
K935923 · IYN
Hewlett-Packard Co.
Radiology · 360d
Cleared Dec 08, 1994
OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS
K941128 · JWH
Osteonics Corp.
Orthopedic · 274d
Cleared Dec 08, 1994
IMMUNOCARD H. PYLORI
K941560 · LYR
Meridian Diagnostics, Inc.
Microbiology · 251d
Cleared Dec 08, 1994
MODEL 6323 OXYGEN CONCENTRATOR
K942082 · CAW
Dynotec Corp.
Anesthesiology · 223d
Cleared Dec 08, 1994
MINIATURIZED FINGER CLIP PULSE OXIMETER
K942248 · DQA
Nonin Medical, Inc.
Anesthesiology · 213d
Cleared Dec 08, 1994
GUIDE WIRE
K942453 · DQX
Boston Scientific Corp
Cardiovascular · 199d
Cleared Dec 08, 1994
CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY
K942843 · HHT
Rovers Diagnostic Devices
Obstetrics & Gynecology · 175d
Cleared Dec 08, 1994
MODEL #300TO3500 SHOULDER COIL
K942874 · LNH
Medic, Inc.
Radiology · 174d
Cleared Dec 08, 1994
POWDER-FREE GLOVES
K943552 · LYY
Healthcare Gloves Sdn Bhd
General Hospital · 140d
Cleared Dec 08, 1994
BONE SCREW
K943804 · HWC
Cohort Medical Products Group, Inc.
Orthopedic · 126d
Cleared Dec 08, 1994
POWDER FREE (SILICONIZED) EXAM GLOVES
K943858 · LYY
Crocker Industrial Resources Sdn. Bhd.
General Hospital · 122d
Cleared Dec 08, 1994
STIMU-TAP
K944024 · ISA
Wahl Clipper Corp.
Physical Medicine · 113d
Cleared Dec 08, 1994
PEANUT WAND, MODIFICATION
K944067 · GCS
Ideal Medical, Inc.
Gastroenterology & Urology · 135d
Cleared Dec 08, 1994
CATHETERS, BILIARY CATHETERS, UROLOGICAL
K944290 · FFA
Boston Scientific Corp
Gastroenterology & Urology · 97d
Cleared Dec 08, 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944299 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 93d
Cleared Dec 08, 1994
BIPOLAR CORD
K944578 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 80d
Cleared Dec 08, 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K944634 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 78d
Cleared Dec 08, 1994
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K944642 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 78d