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
173329–173352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1977
LUTEINIZING HORMONE RIA REAGENT, LH-RIA
K770854 · CEP
Nichols Institute Diagnostics
Immunology · 17d
Cleared May 26, 1977
SYNERVIEW MODEL 6478
K770855 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 17d
Cleared May 26, 1977
SPLINT, COCKUP
K770890 · IQM
Orthopedic Systems, Inc.
Physical Medicine · 10d
Cleared May 26, 1977
SPLINH, FOREARM
K770891 · IQM
Orthopedic Systems, Inc.
Physical Medicine · 10d
Cleared May 26, 1977
PROBE, BLOOD FLOW DETECTOR PLUG-IN
K770904 · KNG
Medsonics
Obstetrics & Gynecology · 10d
Cleared May 26, 1977
PART NO. 66-00311
K770927 · BZG
Harlake Cyprane
Anesthesiology · 6d
Cleared May 26, 1977
PART NO. 66-00121
K770928 · BZG
Harlake Cyprane
Anesthesiology · 6d
Cleared May 25, 1977
ELC-THERMO-SYSTEM
K770678 · KXZ
Cutter Laboratories, Inc.
Radiology · 44d
Cleared May 25, 1977
MICROBIO. PROD. FLUORESCENT ANTIBODY
K770801 · GMY
Pfizer Pharmaceuticals
Immunology · 23d
Cleared May 25, 1977
BRONCHOFIBERSCOPE, FB-19A
K770879
Pilling Co.
Gastroenterology & Urology · 9d
Cleared May 25, 1977
HEARING AID, SERIES K-BEHIND-THE-EAR
K770885 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 9d
Cleared May 25, 1977
MEDISHIELD CERVICAL COLLAR
K770910 · HSS
Fraser Sweatman, Inc.
Physical Medicine · 6d
Cleared May 23, 1977
ISOLATION GOWN
K770488 · FYC
General Medical Co.
General Hospital · 70d
Cleared May 23, 1977
CATHETER, URETHRAL PRESSURE, UPE-10 & 12
K770579 · FAP
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 56d
Cleared May 23, 1977
COTTON BALL KIT
K770588 · FRL
American Hospital Supply Corp.
General Hospital · 56d
Cleared May 23, 1977
FILTER, INTRAVENOUS W/AUTO AIR VENT
K770589 · FPA
Jelco Laboratories
General Hospital · 56d
Cleared May 23, 1977
SUTURE REMOVAL SET
K770595 · JOK
Abco Dealers, Inc.
General Hospital · 56d
Cleared May 23, 1977
ADAPTER, VALVE, ONE WAY BE-130-22
K770627 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 49d
Cleared May 23, 1977
CLAMP BE-152
K770628 · JAY
Instrumentation Industries, Inc.
Anesthesiology · 49d
Cleared May 23, 1977
VALVE, EXHALATION BE 115-4, 115-5
K770629 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 49d
Cleared May 23, 1977
ADAPTER, UNIVERSAL, BE 105-6
K770630 · BZA
Instrumentation Industries, Inc.
Anesthesiology · 49d
Cleared May 23, 1977
FLEX ARM BE 122, CLAMP 122-27
K770631 · JAY
Instrumentation Industries, Inc.
Anesthesiology · 49d
Cleared May 23, 1977
BRACKET BE 122-1
K770633 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 49d
Cleared May 23, 1977
PROTECTOR, HEEL & ELBOW
K770635 · FMP
Tecnol New Jersey Wound Care, Inc.
General Hospital · 49d