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
138433–138456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1987
TRACH COLLAR
K872832 · CBH
Rotek Corp.
Anesthesiology · 49d
Cleared Sep 04, 1987
18MM PEYMAN WIDE FIELD YAG LASER LENS
K872855 · HJK
Ocular Instruments, Inc.
Ophthalmic · 49d
Cleared Sep 04, 1987
STRETCH GAUZE BANDAGES
K872875 · NAD
Abco Dealers, Inc.
General & Plastic Surgery · 45d
Cleared Sep 04, 1987
AMERICAN NASAL SPONGE
K872905 · EPP
American Silk Sutures, Inc.
Ear, Nose, Throat · 42d
Cleared Sep 04, 1987
SPECTRO C
K872941 · GGP
Ramco Laboratories, Inc.
Hematology · 39d
Cleared Sep 04, 1987
LOOK SPRING-ASSIST SYRINGES
K872944 · FMF
Look, Inc.
General Hospital · 38d
Cleared Sep 04, 1987
HEARING AID (ALL-IN-THE-EAR)
K873001 · ESD
Littlefield Co.
Ear, Nose, Throat · 31d
Cleared Sep 04, 1987
POREX OTOLOGY INSTRUMENTS
K873044 · LRC
Porex Medical
Ear, Nose, Throat · 31d
Cleared Sep 04, 1987
PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS
K873097 · GBQ
Ipax, Inc.
General & Plastic Surgery · 39d
Cleared Sep 04, 1987
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K873099 · HNF
Alcon Laboratories
Ophthalmic · 28d
Cleared Sep 04, 1987
UNIFAST GAMMA-GT
K873135 · JQB
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 04, 1987
PERSONNA DISPOSABLE SCALPEL
K873142 · GES
American Safety Razor Co.
General & Plastic Surgery · 25d
Cleared Sep 04, 1987
TREACE MAGNUM OTO-TOOL SYSTEM
K873154 · ERL
Treace Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 04, 1987
VAN DELLEN RETROBULBAR NEEDLE
K873162 · HMX
Van Dellen, Ltd.
Ophthalmic · 24d
Cleared Sep 04, 1987
VAN DELLEN IRRIGATING CYSTOTOME
K873163 · HNY
Van Dellen, Ltd.
Ophthalmic · 24d
Cleared Sep 04, 1987
VAN DELLEN HEALON CANNULA
K873164 · HMX
Van Dellen, Ltd.
Ophthalmic · 24d
Cleared Sep 04, 1987
SURGICAL DRAPE
K873313 · KKX
American Medical Technology, Inc.
General Hospital · 18d
Cleared Sep 04, 1987
HORN CUSTOM AID
K873338 · ESD
Hearing Aids by Guy Horn
Ear, Nose, Throat · 16d
Cleared Sep 03, 1987
CRT PORTABLE EMERGENCY OXYGEN INHALATOR
K872170 · CAN
Cost Reduction Technologies, Inc.
Anesthesiology · 87d
Cleared Sep 03, 1987
SIEMENS O2-AIR MIXER 965
K872278 · BZR
Siemens Elema AB
Anesthesiology · 80d
Cleared Sep 03, 1987
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394 · IMG
Henley Intl.
Physical Medicine · 83d
Cleared Sep 03, 1987
LAKE CATHETER CARE KIT
K872750 · KOD
Lake Medical Products, Inc.
Gastroenterology & Urology · 52d
Cleared Sep 02, 1987
DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
K871328 · LHL
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 152d
Cleared Sep 02, 1987
QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL)
K871903 · JFN
Creative Scientific Technology, Inc.
Chemistry · 110d