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
117625–117648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1992
VERSACATH MAINLINE CENTRAL VENOUS CATHETER
K920128 · FOZ
Menlo Care, Inc.
General Hospital · 73d
Cleared Mar 26, 1992
VERSACATH SELECTALUMEN INNER CATHETER
K920133 · FOZ
Menlo Care, Inc.
General Hospital · 73d
Cleared Mar 26, 1992
MARION WINDOW
K920182 · KGX
Tnt Moberg Intl. , Ltd.
General & Plastic Surgery · 71d
Cleared Mar 26, 1992
DW240 #73C ALLOY FOR PORCELAIN FUSED TO METAL
K920244 · EJT
Ivoclar North America, Inc.
Dental · 69d
Cleared Mar 26, 1992
ULCUFLEX HYDROCOLOID POWDER
K920366 · KMF
Industrias Palex C/O Dma Med-Chem Corp.
General & Plastic Surgery · 58d
Cleared Mar 26, 1992
ULCUFLEX HYDROCULLOID DRESSING
K920367 · KMF
Industrias Palex C/O Dma Med-Chem Corp.
General & Plastic Surgery · 58d
Cleared Mar 26, 1992
ULCUFLEX HYDROCOLLOID PASTE
K920368 · KMF
Industrias Palex C/O Dma Med-Chem Corp.
General & Plastic Surgery · 58d
Cleared Mar 26, 1992
PORCELAIN PRIMER
K920534 · DYH
Confi-Dental Products Co.
Dental · 50d
Cleared Mar 26, 1992
MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER
K920553 · GEX
Myriad Lase, Inc.
General & Plastic Surgery · 49d
Cleared Mar 26, 1992
VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
K920856 · JLW
Hycor Biomedical, Inc.
Chemistry · 37d
Cleared Mar 26, 1992
ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY
K920917 · CGJ
Bio Clinic Co.
Chemistry · 27d
Cleared Mar 26, 1992
DENTOLOCK
K921071 · KOB
Dentmed , Ltd.
Gastroenterology & Urology · 20d
Cleared Mar 25, 1992
MODEL 704
K912139 · GWM
Ivy Biomedical Systems, Inc.
Neurology · 316d
Cleared Mar 25, 1992
CONVERBASE
K912990 · EBI
Wilde-USA, Inc.
Dental · 261d
Cleared Mar 25, 1992
BREATHE EASY
K914336 · BYD
Vital Signs, Inc.
Anesthesiology · 180d
Cleared Mar 25, 1992
MEPITEL NON-ADHERENT SILICONE DRESSING
K914604 · NAB
Molnlycke Clinical Products AB
General & Plastic Surgery · 160d
Cleared Mar 25, 1992
SUNGLASSES/READING GLASSES
K915263 · HQY
Royalking Industrial Corp.
Ophthalmic · 127d
Cleared Mar 25, 1992
AMALCODEN
K915666 · EMA
Mion International Corp.
Dental · 98d
Cleared Mar 25, 1992
LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
K920021 · JDI
Implant Technology, Inc.
Orthopedic · 83d
Cleared Mar 25, 1992
SMART BURS TOTAL CARBIDES
K920243 · EJL
Vermont Diamond Instruments
Dental · 68d
Cleared Mar 24, 1992
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · CCW
Vital Signs, Inc.
Anesthesiology · 487d
Cleared Mar 24, 1992
OLYMPUS DISPOSABLE SUCTION VALVE
K920025 · EOQ
Olympus Corp.
Ear, Nose, Throat · 81d
Cleared Mar 24, 1992
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD
K920335 · CKA
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Mar 24, 1992
DIRECT PREGNANCY TEST
K920716 · JHJ
Tech-Co, Inc.
Chemistry · 35d