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
81481–81504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2000
ACCUSONIC PLUS, MODEL AP-100
K001370 · IMI
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 77d
Cleared Jul 17, 2000
ACCUSET SENSOR, MODEL 2000
K001386 · FEN
Pelvicare, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 17, 2000
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
K001582 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Jul 17, 2000
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
K001698 · FFS
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 45d
Cleared Jul 17, 2000
GC FUJICEM
K001730 · EMA
GC America, Inc.
Dental · 40d
Cleared Jul 17, 2000
ARTHROCARE FLOW CONTROL UNIT
K001904 · GEI
Arthrocare Corp.
General & Plastic Surgery · 25d
Cleared Jul 17, 2000
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
K993996 · MEG
Univec, Inc.
General Hospital · 236d
Cleared Jul 17, 2000
PHARMASEED, MODEL BT-125-3
K994018 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 234d
Cleared Jul 14, 2000
SAMARCO SPIDER PLATES
K001271 · KTW
Biomet, Inc.
Orthopedic · 85d
Cleared Jul 14, 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K001924 · KGO
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Jul 14, 2000
PHARMASEED, MODEL BT-103-3
K994016 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 231d
Cleared Jul 13, 2000
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · MSX
Datex-Ohmeda, Inc.
Cardiovascular · 136d
Cleared Jul 13, 2000
ISOLETTE INFANT INCUBATOR, MODEL C2HS
K001242 · FMZ
Hill-Rom Air-Shields
General Hospital · 86d
Cleared Jul 13, 2000
WELCH ALLYN INSTRUMENT INTERFACE MODULE
K001265 · MWI
Welch Allyn, Inc.
Cardiovascular · 85d
Cleared Jul 13, 2000
RETCAM II
K001275 · HKI
Massie Research Laboratories, Inc.
Ophthalmic · 84d
Cleared Jul 13, 2000
ISLAND BIOSURGICAL BNS KIT #3
K001583 · KOD
Island Biosurgical, LLC
Gastroenterology & Urology · 52d
Cleared Jul 13, 2000
FOCUS
K001729 · EHD
Instrumentarium Corp.
Radiology · 36d
Cleared Jul 13, 2000
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001747 · LLZ
Barco NV Display Systems
Radiology · 35d
Cleared Jul 13, 2000
ELECSYS INSULIN CALSET
K001906 · JIS
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 13, 2000
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
K002003 · IYN
Atl Ultrasound, Inc.
Radiology · 13d
Cleared Jul 13, 2000
POCKET ULTRASONIC PACHYMETER
K993674 · IYO
Quantel Medical
Radiology · 255d
Cleared Jul 13, 2000
BRAINSCAN
K994413 · MUJ
Brainlab AG
Radiology · 197d
Cleared Jul 12, 2000
AMT THERAPEUTIC TABLE, MODEL 748AMT
K001401 · ITH
Amt Mfg., Inc.
Physical Medicine · 70d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · DKZ
Roche Diagnostics Corp.
Toxicology · 68d