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
133777–133800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1988
HYSTERO KIT
K882054 · HDP
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 136d
Cleared Sep 29, 1988
DRY COMFORT UNDERGARMENT
K882418 · EYQ
Health Tec, Inc.
Gastroenterology & Urology · 108d
Cleared Sep 29, 1988
PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535
K882886 · GXY
Medical Devices, Inc.
Neurology · 80d
Cleared Sep 29, 1988
PROGEL(TM), MODELS 8630 AND 8635
K882887 · GXY
Medical Devices, Inc.
Neurology · 80d
Cleared Sep 29, 1988
PULMONARY FORCED FLOW SYSTEM (PUFFS)
K883008 · BTY
Medical Associated Services, Inc.
Anesthesiology · 73d
Cleared Sep 29, 1988
MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND
K883023 · GDS
Mentor Corp.
Gastroenterology & Urology · 72d
Cleared Sep 29, 1988
SKIFA, PLASTIC DISPOSABLE SYRINGE
K883227 · FMF
P.T. Setio Harto , Ltd.
General Hospital · 59d
Cleared Sep 29, 1988
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280 · KGI
Hologic, Inc.
Radiology · 57d
Cleared Sep 29, 1988
BARD BIOPSY NEEDLE GUIDANCE DEVICE
K883374 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 51d
Cleared Sep 29, 1988
ACCUFLO UF CONTROL MODULE NO. 74-0100-3
K883490 · FJB
National Medical Care, Medical...
Gastroenterology & Urology · 44d
Cleared Sep 29, 1988
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
K883589 · FJI
Gambro, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 29, 1988
LECTROSPIRAL
K883612 · FPA
Vygon Corp.
General Hospital · 38d
Cleared Sep 29, 1988
FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE
K883856 · HBI
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
FIBEROPTIC WIRE PICK LIGHTPIPE
K883857 · HBI
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
K883858 · HBI
Advanced Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Sep 29, 1988
MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER
K883950 · CCK
Fenem, Inc.
Anesthesiology · 21d
Cleared Sep 28, 1988
TENSTAR
K874818 · GZJ
Healthcheck Corp.
Neurology · 309d
Cleared Sep 28, 1988
VASCUCARE ANGIOPUMP
K881780 · DWB
Vascucare, Inc.
Cardiovascular · 155d
Cleared Sep 28, 1988
MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
K881825 · DYB
Spectramed, Inc.
Cardiovascular · 152d
Cleared Sep 28, 1988
ACS SCHWARTEN XT BALLOON DILATATION CATHETER
K882925 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Sep 28, 1988
ACS ANGIOSCOPE GUIDE WIRE
K883000 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d
Cleared Sep 28, 1988
4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02
K883089 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 69d
Cleared Sep 28, 1988
TEN20 CONDUCTIVE
K883149 · GYB
Weaver & Co.
Neurology · 64d
Cleared Sep 28, 1988
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K883345 · DTN
3M Health Care, Sarns
Cardiovascular · 50d