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
90817–90840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1997
HARMONIC IMAGING WITH CONTRAST
K973767 · IYO
Acuson Corp.
Radiology · 82d
Cleared Dec 23, 1997
DUODERM HYDROACTIVE PASTE
K973807 · FRO
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 78d
Cleared Dec 23, 1997
LEVO COMPACT-EASY LCE
K973951 · IPL
Levo USA
Physical Medicine · 68d
Cleared Dec 23, 1997
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · KPI
Hollister, Inc.
Gastroenterology & Urology · 60d
Cleared Dec 23, 1997
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · JDI
Howmedica, Inc.
Orthopedic · 57d
Cleared Dec 23, 1997
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
K974306 · CEW
Sangui Biotech, Inc.
Chemistry · 36d
Cleared Dec 22, 1997
DAXOR MAX100 SYRINGE (MAX100)
K970419 · FMF
Daxor Corporation
General Hospital · 321d
Cleared Dec 22, 1997
GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM
K970901 · IYO
GE Medical Systems
Radiology · 286d
Cleared Dec 22, 1997
SYNTEX
K971360 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 255d
Cleared Dec 22, 1997
NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET
K971582 · LJT
Nipro Medical Corp.
General Hospital · 236d
Cleared Dec 22, 1997
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · GOD
Immunoprobe, Inc.
Microbiology · 179d
Cleared Dec 22, 1997
CATHETER TUNNELER
K972555 · LJS
Gerard Medical, Inc.
General Hospital · 168d
Cleared Dec 22, 1997
SYVEK PATCH
K972914 · KGX
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 137d
Cleared Dec 22, 1997
SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT...
K973513 · EBF
Espe GmbH & Co. Kg.
Dental · 96d
Cleared Dec 22, 1997
DUODERM CGF CONTROL GEL FORMULA DRESSING
K973632 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 89d
Cleared Dec 22, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
K973686 · GEH
Endocare, Inc.
General & Plastic Surgery · 87d
Cleared Dec 22, 1997
AUKLET CT SCANNER, TSX-003A
K973908 · JAK
Toshiba America Medical Systems, In.C
Radiology · 69d
Cleared Dec 22, 1997
IMAGEN RESPIRATORY SCREEN
K973954 · GNW
Dako Diagnostics , Ltd.
Microbiology · 74d
Cleared Dec 22, 1997
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
K973959 · LMD
Olicon Imaging Systems, Inc.
Radiology · 67d
Cleared Dec 22, 1997
RDI HOMOGENEOUS HDL CHOLESTEROL TEST
K973988 · LBS
Reference Diagnostics, Inc.
Chemistry · 62d
Cleared Dec 22, 1997
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE,...
K974032 · HFC
A & A Medical, Inc.
Obstetrics & Gynecology · 60d
Cleared Dec 22, 1997
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
K974036 · HIR
The Prometheus Group
Gastroenterology & Urology · 59d
Cleared Dec 22, 1997
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95...
K974068 · MSH
Tecnol Medical Products, Inc.
General Hospital · 55d
Cleared Dec 22, 1997
TAKY-SPIKE PLUS
K974198 · LHI
Clinico
General Hospital · 42d