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
145705–145728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1985
THE HOOD LIFE SAVER
K853511 · BTO
Hood Laboratories
Anesthesiology · 120d
Cleared Dec 19, 1985
QUANTTEST TOTAL PROTEIN ASSAY
K853932 · CEK
Quantimetrix Corp.
Chemistry · 86d
Cleared Dec 19, 1985
IN VITRO TEST DETERMINATION OF THEOPHYLLINE
K854183 · KLS
Clinical Data, Inc.
Toxicology · 65d
Cleared Dec 19, 1985
ARI STANDARD ANESTHESIA RECORD
K854213 · BSZ
Agilent Technologies, Inc.
Anesthesiology · 63d
Cleared Dec 19, 1985
MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA
K854550 · CCQ
Medipart Jerry Alexander
Anesthesiology · 36d
Cleared Dec 19, 1985
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S
K854551 · CCQ
Medipart Jerry Alexander
Anesthesiology · 36d
Cleared Dec 19, 1985
LONG TERM PERITONEAL CATHETER
K854614 · FJS
Thermadics, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 19, 1985
DSL ACTIVE TESTOSTERONE RIA (DSL #4000)
K854671 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Dec 19, 1985
DSL ANDROSTENDIONE RIA (DSL #4200)
K854674 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 28d
Cleared Dec 19, 1985
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926
K854718 · CIX
Nobel Scientific Industries, Inc.
Chemistry · 27d
Cleared Dec 19, 1985
ABSORBANCE (ABS) TEST PAK
K854784 · JIT
Diagnostic Systems
Chemistry · 20d
Cleared Dec 19, 1985
EPIDURAL ANESTHESIA NEEDLES
K854816 · BSP
Reganes, Inc.
Anesthesiology · 16d
Cleared Dec 19, 1985
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
K854919 · DXY
Cook Pacemaker Corp.
Cardiovascular · 10d
Cleared Dec 18, 1985
DEN-MAT PAINT-ON RUBBER DAM
K852630 · EIE
Den-Mat Corp.
Dental · 181d
Cleared Dec 18, 1985
FIBRELIGHT NASAL SPECULA
K853588 · EPY
Downs Surgical , Ltd.
General & Plastic Surgery · 113d
Cleared Dec 18, 1985
BRONCHIAL CYTOLOGY BRUSH
K853667
E-Z-Em, Inc.
Cardiovascular · 106d
Cleared Dec 18, 1985
5.0 MHZ INTRACAVITARY SECTOR PROBE
K853711 · HEM
General Electric Co.
Obstetrics & Gynecology · 104d
Cleared Dec 18, 1985
MODEL 310 IMPEDANCE SYSTEM
K853863 · ETY
Virtual Corp.
Ear, Nose, Throat · 92d
Cleared Dec 18, 1985
MA25 PORTABLE AUDIOMETER
K853919 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 86d
Cleared Dec 18, 1985
INT'L MODEL XG BEHIND-THE-EAR HEARING AID
K853941 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 1985
INT'L MODEL XE BEHIND-THE-EAR HEARING AID
K853942 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 1985
INFUSAID INFUSE-A-PORT (MODIFIED)
K853981 · LJT
Intermedics/Infusaid, Inc.
General Hospital · 82d
Cleared Dec 17, 1985
PVL-4.8-200 BALLOON STONE EXTRACTOR
K851954 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 228d
Cleared Dec 17, 1985
ZIMMON BILIARY STENT SET
K851962 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 228d