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
114505–114528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1993
AUDIOTONE MODEL A-98
K926091 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 12, 1993
MIRACLE-EAR MODEL HL
K926092 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 12, 1993
FLUOREX
K926122 · JAA
Toshiba America Medical Systems, In.C
Radiology · 70d
Cleared Feb 12, 1993
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
K926222 · JPA
Helena Laboratories
Hematology · 64d
Cleared Feb 12, 1993
SAFE-T-TUBE RADIOPAQUE
K930150 · BTR
Boston Medical Products, Inc.
Anesthesiology · 39d
Cleared Feb 10, 1993
ANSPACH MINI-PLATING SYSTEM
K921338 · HRS
The Anspach Effort, Inc.
Orthopedic · 329d
Cleared Feb 10, 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · DSP
Datascope Corp.
Cardiovascular · 310d
Cleared Feb 10, 1993
HOLDER, PEDIATRIC POSITION
K922288 · BWN
Yamashita and Hemsley Business Trust
General & Plastic Surgery · 271d
Cleared Feb 10, 1993
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · DQA
Hewlett-Packard Co.
Anesthesiology · 237d
Cleared Feb 10, 1993
MINIVASIVE LAPAROSCOPY INSTRUMENTS
K923547 · GCJ
Minvasive Devices, Inc.
General & Plastic Surgery · 209d
Cleared Feb 10, 1993
LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)
K923862 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 191d
Cleared Feb 10, 1993
TORQR SERIES DIAGNOSTIC EP CATHETERS
K923915 · DRF
Cardiorhythm
Cardiovascular · 204d
Cleared Feb 10, 1993
VOYAGR SERIES DIAGNOSTIC EP CATHETERS
K923916 · DRF
Cardiorhythm
Cardiovascular · 197d
Cleared Feb 10, 1993
PERRY POWDER-FREE GLOVES, STYLE 45G
K923929 · KGO
Smith & Nephew Perry
General Hospital · 189d
Cleared Feb 10, 1993
CHOLANGIOGRAPHY CATHETER
K924128 · GBZ
Applied Medical Resources
General & Plastic Surgery · 177d
Cleared Feb 10, 1993
DOCTOR'S CHOICE POWDER FREE LATEX EXAM GLOVES
K924266 · LYY
Chesire Laboratories
General Hospital · 170d
Cleared Feb 10, 1993
MICROSURGE DIRECTOR ARTICULATING INSTRUMENTS
K924284 · GCJ
Micromec Surgical, Inc.
General & Plastic Surgery · 169d
Cleared Feb 10, 1993
CIR LATEX GLOVES
K924419 · LYY
Crocker Industrial Resources Sdn. Bhd.
General Hospital · 163d
Cleared Feb 10, 1993
REUSABLE INCONTIENT UNDERPAD
K924807 · FMW
Perfect Fit Industries, Inc.
General Hospital · 160d
Cleared Feb 10, 1993
GRASPING FORCEPS OR RETRIEVAL FORCEPS
K925267 · GCJ
Annex Medical, Inc.
General & Plastic Surgery · 114d
Cleared Feb 10, 1993
REUSABLE FINGER CLIP RECORDING ELECTRODE
K925706 · GXY
Chalgren Enterprises, Inc.
Neurology · 90d
Cleared Feb 10, 1993
ENDOSCOPE AND ACCOSSORIES
K926004 · FGB
Endomedix
Gastroenterology & Urology · 75d
Cleared Feb 09, 1993
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
K914273 · DSK
A&D Engineering, Inc.
Cardiovascular · 504d
Cleared Feb 09, 1993
ARTHREX CANNULATED INTERFERENCE SCREW
K915424 · HWC
Arthrex, Inc.
Orthopedic · 435d