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
155449–155472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1983
DOSIMETRY RELEASE OF RADIATION STERILIZ
K831512 · JDK
Biomet, Inc.
Orthopedic · 140d
Cleared Sep 29, 1983
H-FLU B ELISA TEST
K831525 · GRP
Seragen Diagnostics, Inc.
Microbiology · 140d
Cleared Sep 29, 1983
BIOCHECK PEC-108 PROGRAM-PULSE MONITOR
K831752 · DRT
Biotechnology, Inc.
Cardiovascular · 120d
Cleared Sep 29, 1983
ANSPACH 65,000
K831756 · HSZ
The Anspach Effort, Inc.
Orthopedic · 120d
Cleared Sep 29, 1983
PATIENT MONITOR #78353A
K831787 · DRT
Hewlett-Packard Co.
Cardiovascular · 118d
Cleared Sep 29, 1983
CARDIO-SCOPE MINI MONITOR
K831878 · DPS
W.E. Leder Enterprises, Inc.
Cardiovascular · 108d
Cleared Sep 29, 1983
BASIC BREAST PUMP
K831929 · HGY
Terayco Intl., Ltd.
Obstetrics & Gynecology · 106d
Cleared Sep 29, 1983
LARYNGESCOPE
K831981 · CCW
W.E. Leder Enterprises, Inc.
Anesthesiology · 101d
Cleared Sep 29, 1983
FEMORAL CANAL SUCTION TAMPON
K831999 · JOL
Richards Manufacturer Co.
General Hospital · 100d
Cleared Sep 29, 1983
HEPARIN COATED STAINLESS STEEL/TEFLON
K832030 · DOX
Argon Medical Corp.
Toxicology · 98d
Cleared Sep 29, 1983
STERILE FLUID PRODUCING UNIT #EP550
K832040 · LJH
American Cystocope Makers, Inc.
Gastroenterology & Urology · 97d
Cleared Sep 29, 1983
SHILEY MULTIPRO CATHETER
K832044 · DXE
Shiley, Inc.
Cardiovascular · 97d
Cleared Sep 29, 1983
SINGLE PATIENT SYS. II MODEL DM-450
K832053 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 94d
Cleared Sep 29, 1983
CONTROL 282
K832066 · JKS
Bio-Nustics, Inc.
Chemistry · 94d
Cleared Sep 29, 1983
MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT
K832077 · LJP
Syva Co.
Microbiology · 93d
Cleared Sep 29, 1983
MICRO TRAK CHLAMYDIA TRAC CONTROL SLID
K832078 · LJP
Syva Co.
Microbiology · 93d
Cleared Sep 29, 1983
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079 · LIO
Syva Co.
Microbiology · 93d
Cleared Sep 29, 1983
REXTON RX10, RX20-30 & 40
K832180 · ESD
Rexton, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 29, 1983
DOSIMETRIC RELEASE OF GAMMA RADIATION
K832211 · JDI
Kirschner Medical Corp.
Orthopedic · 85d
Cleared Sep 29, 1983
RUBASCAN LATEX CARD TEST
K832228 · GOK
Bd Becton Dickinson Vacutainer...
Microbiology · 80d
Cleared Sep 29, 1983
DISPOSABLE VITRECTOMY HANDPIECE
K832235 · HQE
Innovative Surgical Products, Inc.
Ophthalmic · 80d
Cleared Sep 29, 1983
CULTURE MEDIUM FOR ANTIMICROBIAL SUS
K832243 · JTZ
Carroll Biological Corp.
Microbiology · 83d
Cleared Sep 29, 1983
LIGHT HANDLE COVER
K832278 · KKX
Concept, Inc.
General Hospital · 79d
Cleared Sep 29, 1983
BEHIND-THE-EAR #123 AGCI
K832326 · ESD
Danavox, Inc.
Ear, Nose, Throat · 76d