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
172849–172872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1977
PEAK FLOW METER
K770580 · BZH
Projects IN Health
Anesthesiology · 129d
Cleared Aug 04, 1977
TUBING PACK, EXTRACORPOREAL, H-3000
K770720 · BYS
William Harvey Life Products Corp.
Cardiovascular · 108d
Cleared Aug 04, 1977
TRAY, PRESSURE, INTRACOMPARTMENTAL,WICK
K770776
Cutter Laboratories, Inc.
Cardiovascular · 98d
Cleared Aug 04, 1977
INCUBATOR, PORTABLE, ACT-STAT
K770914 · KQG
Thermolyne Corp.
Hematology · 77d
Cleared Aug 04, 1977
CARDIOZYME CK-CONTROL ABNORMAL
K770971 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Aug 04, 1977
CARDIOZYME CK CONTROL NORMAL
K770973 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Aug 04, 1977
SMAC SYS., SUPPLEMENTAL PRODUCTS FOR
K771033 · CKA
Mid Tech, Inc.
Chemistry · 56d
Cleared Aug 04, 1977
HI-MID CURCUIT
K771034 · CAI
Draeger Medical, Inc.
Anesthesiology · 55d
Cleared Aug 04, 1977
NASAL OXYGEN CANNULA, #017207
K771074 · CAT
C.R. Bard, Inc.
Anesthesiology · 51d
Cleared Aug 04, 1977
OXYGEN CONNECTING TUBE #017205
K771075 · BYX
C.R. Bard, Inc.
Anesthesiology · 51d
Cleared Aug 04, 1977
DYNAZYME II Y-GT
K771084
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Aug 04, 1977
DYNAZYME II ALKALINE PHOSPHATASE
K771085 · CJE
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Aug 04, 1977
BLOOD GROUPING SYS., BG-9
K771098 · KSZ
Technicon Instruments Corp.
Hematology · 45d
Cleared Aug 04, 1977
VERI/CTGS MODEL 850
K771122 · GZJ
Verite Scientific, Inc.
Neurology · 43d
Cleared Aug 04, 1977
AUTO-LOGIC II SYSTEM
K771129 · JJJ
Abbott Laboratories
Chemistry · 42d
Cleared Aug 04, 1977
PIPETS UNIFORM DROP SIZE BOROSILICATE
K771137 · GJW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 04, 1977
PIPETS BOROSILICATE GLASS
K771138 · GJW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 04, 1977
COPPER KETTLE VAPORIZER PLUS
K771150 · CAD
Air Products & Chemicals, Inc.
Anesthesiology · 38d
Cleared Aug 04, 1977
ARTIUS SYSTEM
K771151 · HGL
General Electric Co.
Obstetrics & Gynecology · 41d
Cleared Aug 04, 1977
ANTI-MITOCHONDRIAL
K771155 · DBE
Meloy Laboratories, Inc.
Immunology · 37d
Cleared Aug 04, 1977
ANESTHESIA RESPIRATOR
K771217 · BZD
Rule Medical Instruments, Inc.
Anesthesiology · 30d
Cleared Aug 04, 1977
BRONCHO-CATH
K771219 · BTS
Mallinckrodt Critical Care
Anesthesiology · 30d
Cleared Aug 04, 1977
T3 RIA TEST SYSTEM
K771220 · CDP
Monobind
Chemistry · 30d
Cleared Aug 04, 1977
T4 RIA TEST SYSTEM
K771221 · CDX
Monobind
Chemistry · 30d