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
144601–144624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1986
7.5 MHZ LINEAR ARRAY SONOLINE PROBE
K854667 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Mar 20, 1986
5.0 MHZ LINEAR ARRAY SONOLINE PROBE
K854668 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Mar 20, 1986
COTTON NEUROLOGICAL SPONGE
K854713 · HBA
American Silk Sutures, Inc.
Neurology · 118d
Cleared Mar 20, 1986
RESPIGRAPH
K854956 · BZK
Respitrace Corp.
Anesthesiology · 99d
Cleared Mar 20, 1986
LARYNGEAL MIRROR PRE-WARMER
K855021 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 94d
Cleared Mar 20, 1986
MYOTEST - NERVE STIMULATOR
K860186 · BXN
Biometer Intl. A/S
Anesthesiology · 57d
Cleared Mar 20, 1986
MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING
K860187 · BXN
Biometer Intl. A/S
Anesthesiology · 57d
Cleared Mar 20, 1986
DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS
K860439 · EJS
Williams Gold Refining Co., Inc.
Dental · 44d
Cleared Mar 20, 1986
KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL
K860532 · ELW
Kerr Corporation (Danbury)
Dental · 36d
Cleared Mar 20, 1986
RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM
K860606 · LHN
Bionix Corp.
Radiology · 29d
Cleared Mar 20, 1986
VENTURI MASK/ADULT & PAEDIATRIC
K860873 · BYF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
CIRRUS DRUG NEBULIZER MK III
K860875 · CCQ
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
FLEXTUBE, CONNECTING TUBING
K860877 · BYX
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
BRITISH BREATHING CIRCUIT SYSTEM
K860878 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
DISPOSABLE VENTILATOR CIRCUITS
K860879 · BZO
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
VENTILATOR CIRCUITS (VARIOUS TYPES)
K860880 · BZO
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
DISPOSABLE CATHETER
K860882 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
STRAIGHT CONNECTORS, 15MM, 30MM & 19MM
K860885 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 23d
Cleared Mar 20, 1986
MARK 4 LIQUID OXYGEN SYSTEM
K860937 · BYJ
Puritan Bennett Corp.
Anesthesiology · 8d
Cleared Mar 19, 1986
MICRO-MEDIA MICRODILUTION TEST PANELS
K853805 · JWY
Beckman Instruments, Inc.
Microbiology · 189d
Cleared Mar 19, 1986
AESCULAP BONE MILL
K860016 · LYS
Aesculap Instruments Corp.
Orthopedic · 75d
Cleared Mar 19, 1986
ACROMED SPINAL SURGERY INSTRUMENTS
K860131 · LXH
Buckman Co., Inc.
Orthopedic · 64d
Cleared Mar 19, 1986
SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014
K860352 · BZA
Spacelabs, Inc.
Anesthesiology · 48d
Cleared Mar 19, 1986
ACE IM ROD
K860592 · HSB
Buckman Co., Inc.
Orthopedic · 28d