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
145609–145632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1986
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
K854081 · GQG
Boots-Celltech Diagnostics, Inc.
Microbiology · 88d
Cleared Jan 03, 1986
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
K854212 · BZT
Respiratory Support Products, Inc.
Anesthesiology · 78d
Cleared Jan 03, 1986
OXYGEN CONCENTRATOR, MODEL BX-5000
K854374 · CAW
Healthdyne, Inc.
Anesthesiology · 65d
Cleared Jan 03, 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K854447 · GTZ
American Micro Scan
Microbiology · 59d
Cleared Jan 03, 1986
ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE
K854573 · CAI
Artec Environmental Monitoring Division
Anesthesiology · 50d
Cleared Jan 03, 1986
ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
K854612 · LFK
Med-West, Inc.
Gastroenterology & Urology · 46d
Cleared Jan 03, 1986
ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE
K854632 · BTR
Respiratory Support Products, Inc.
Anesthesiology · 43d
Cleared Jan 03, 1986
ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR
K854635 · INQ
Electra Equipment , Ltd.
Physical Medicine · 45d
Cleared Jan 03, 1986
CHURCHHILL LANCET
K854760 · FMK
Churchill Corp.
General & Plastic Surgery · 37d
Cleared Jan 03, 1986
SETMA HYGIA BATH MODEL ST 7200
K854861 · ILJ
Setma, Inc.
Physical Medicine · 29d
Cleared Jan 03, 1986
REHABILITATION TABLES
K854947 · INQ
I-Rep, Inc.
Physical Medicine · 24d
Cleared Jan 03, 1986
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
K854986 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 22d
Cleared Jan 01, 1986
HYDRO-BAC FILTER
K852866 · CAI
Medicomp, Inc.
Anesthesiology · 177d
Cleared Jan 01, 1986
JECT-AID
K853031 · KZE
Autoject Systems, Inc.
General Hospital · 167d
Cleared Jan 01, 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · LFX
Hybritech, Inc.
Microbiology · 163d
Cleared Jan 01, 1986
ACE COMPUTER SYSTEM
K853482 · IYX
Cardiac Medical Systems Corp.
Radiology · 134d
Cleared Jan 01, 1986
KODAK M35 X-OMAT PROCESSOR
K854219 · IXW
Eastman Kodak Company
Radiology · 76d
Cleared Jan 01, 1986
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K854242 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 72d
Cleared Jan 01, 1986
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · GKZ
Abbott Diagnostics
Hematology · 64d
Cleared Jan 01, 1986
MINXRAY 500M MAMMOGRAPHIC SYSTEM
K854510 · IZH
Minxray, Inc.
Radiology · 50d
Cleared Dec 31, 1985
DIASONICS ADA400 ADVANCED DIGITAL ARRAY
K851972 · IYO
Diasonics, Inc.
Radiology · 238d
Cleared Dec 31, 1985
CERTI-FORM
K854001 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 92d
Cleared Dec 31, 1985
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
K854043 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 90d
Cleared Dec 31, 1985
CSM MEDIUM
K854052 · LYX
Northern Scientific, Inc.
Ophthalmic · 89d