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
104065–104088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1995
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · KNT
Abbott Laboratories
Gastroenterology & Urology · 1023d
Cleared Mar 01, 1995
SANDBLASTER
K931845 · KOJ
Mirage Dental Systems
Dental · 687d
Cleared Mar 01, 1995
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · GWM
Cordis Corp.
Neurology · 379d
Cleared Mar 01, 1995
MODEL IM77 INTRAPARTUM FETAL MONITOR
K940898 · HGM
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 370d
Cleared Mar 01, 1995
CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
K941547 · BYK
Allied Healthcare Products, Inc.
Anesthesiology · 336d
Cleared Mar 01, 1995
POCKET PUMP
K942378 · FRN
Baxa Infusion Systems
General Hospital · 286d
Cleared Mar 01, 1995
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
K942700 · MHX
Critikon Company, LLC
Cardiovascular · 266d
Cleared Mar 01, 1995
BUN REAGENT
K942984 · CDQ
American Research Products Co.
Chemistry · 254d
Cleared Mar 01, 1995
DOFI RASTER-SCREEN
K943554 · GCJ
Howrey & Simon
General & Plastic Surgery · 223d
Cleared Mar 01, 1995
TUNNELER
K943968 · MDM
Denver Biomedicals, Inc.
General & Plastic Surgery · 198d
Cleared Mar 01, 1995
KIS-II IMPLANT FIXTURES
K943971 · DZE
Implant Center of the Palm Beaches
Dental · 198d
Cleared Mar 01, 1995
KIS-II NON-ANGULATED ABUTMENTS
K943984 · DZE
Implant Center of the Palm Beaches
Dental · 197d
Cleared Mar 01, 1995
ULTRASOUND 77030 IMAGING SYSTEM
K944048 · IYN
Hewlett-Packard Co.
Radiology · 195d
Cleared Mar 01, 1995
MONOJECT(R) PISTON SYRINGES
K945715 · FMF
Sherwood Medical Co.
General Hospital · 100d
Cleared Mar 01, 1995
BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS
K945832 · NAE
Brady Medical Products Co.
General & Plastic Surgery · 92d
Cleared Mar 01, 1995
BERGEN 710 ESU
K945861 · HAM
Bergen Mfg.
General & Plastic Surgery · 90d
Cleared Mar 01, 1995
VIDEO VISION ANALYZER (VIVA), VRB 100
K945959 · HKO
Tomey Corporation USA
Ophthalmic · 84d
Cleared Mar 01, 1995
IMPLANT BODY RETRIEVER/REMOVER
K946113 · DZE
"O" Co., Inc.
Dental · 76d
Cleared Mar 01, 1995
EK-VIEW(TM) ECG MANAGEMENT SYSTEM
K946115 · DXG
Apcot Medical Systems
Cardiovascular · 76d
Cleared Mar 01, 1995
IMPLANT BODY DEPTH GAUGE/TRYIN
K946129 · DZE
"O" Co., Inc.
Dental · 75d
Cleared Mar 01, 1995
SPIRIT II AND SPIRIT TREATMENT CENTER
K946187 · EIA
Pelton & Crane Co.
Dental · 71d
Cleared Mar 01, 1995
DMA ALBUMIN PROCEDURE
K946355 · CIX
Data Medical Associates, Inc.
Chemistry · 61d
Cleared Mar 01, 1995
KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000
K950091 · HKI
Konan Medical, Inc.
Ophthalmic · 50d
Cleared Mar 01, 1995
DUMEX WET DRESSINGS
K950132 · FRO
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 47d