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
117529–117552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1992
UNISCAN 24 ECG ROCORDER
K920572 · DSH
Uniscan , Ltd.
Cardiovascular · 59d
Cleared Apr 06, 1992
AVI MODEL 3000 INFUSION PUMP
K920588 · FRN
3M Health Care, Ltd.
General Hospital · 56d
Cleared Apr 06, 1992
E-Z SET/MINICATH INFUSION SETS
K920635 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 54d
Cleared Apr 06, 1992
AVI MODEL 275CI INFUSION PUMP
K920680 · FRN
3M Health Care, Ltd.
General Hospital · 52d
Cleared Apr 06, 1992
AVI MODEL 285CI INFUSION PUMP
K920681 · FRN
3M Health Care, Ltd.
General Hospital · 52d
Cleared Apr 03, 1992
DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT
K920044 · KXO
Telos Medical Corp.
Obstetrics & Gynecology · 88d
Cleared Apr 03, 1992
HEALTH PAK TRAY SOX BARRIERS
K920052 · KKX
Healthpak, Inc.
General Hospital · 88d
Cleared Apr 02, 1992
SACA, 3.5 MHZ PROBE
K905200 · ITX
Diasonics, Inc.
Radiology · 499d
Cleared Apr 02, 1992
SPORE STRIP
K912796 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 282d
Cleared Apr 02, 1992
LAPAROSTAT(TM)
K913300 · HAM
Cook Ob/Gyn
General & Plastic Surgery · 252d
Cleared Apr 02, 1992
BIPLANE TRANSRECTAL PROBE
K914006 · ITX
Biosound, Inc.
Radiology · 206d
Cleared Apr 02, 1992
OTT INSUFFLATOR FILTER PLUS/TUBING SET
K914153 · HIF
Marlo Surgical Technology
Obstetrics & Gynecology · 199d
Cleared Apr 02, 1992
SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
K914329 · HGI
Ellman Intl. Mfg., Inc.
Obstetrics & Gynecology · 188d
Cleared Apr 02, 1992
STRAP, HEAD, GAS MASK
K914335 · BTK
Vital Signs, Inc.
Anesthesiology · 188d
Cleared Apr 02, 1992
KTP/YAG AND KTP/YAG PLUS
K914518 · GEX
Laserscope
General & Plastic Surgery · 176d
Cleared Apr 02, 1992
COMPEL E
K914839 · FYA
Standard Textile Co., Inc.
General Hospital · 160d
Cleared Apr 02, 1992
AQUA MED
K914943 · ISA
Aqua Massage Intl., Inc.
Physical Medicine · 150d
Cleared Apr 02, 1992
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K915117 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 141d
Cleared Apr 02, 1992
DEXTER HAND EVALUATION AND THERAPY SYSTEM
K915144 · IKK
Cedars Medical Center
Physical Medicine · 140d
Cleared Apr 02, 1992
EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM
K915169 · GEX
Excel Tech. , Ltd.
General & Plastic Surgery · 139d
Cleared Apr 02, 1992
ACCUPACE GROUP A STREPTOCOCCUS ID TEST
K915852 · MDK
Gen-Probe, Inc.
Microbiology · 97d
Cleared Apr 02, 1992
LATEX PATIENT EXAMINATION GLOVES
K915872 · LYY
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 119d
Cleared Apr 02, 1992
DENTAL SOLDER ALLOY
K920060 · EJT
Deringer-Ney, Inc.
Dental · 87d
Cleared Apr 02, 1992
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
K920110 · GEA
Ethicon, Inc.
General & Plastic Surgery · 86d