FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82897–82920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2000
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
K993608 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 171d
Cleared Apr 13, 2000
LIGA-LOOP SUTURE APPLICATOR
K993695 · GAL
Hysterx, Inc.
General & Plastic Surgery · 163d
Cleared Apr 13, 2000
ACTIVATOR PASTE
K994027 · ELW
Harry J. Bosworth Co.
Dental · 139d
Cleared Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164 · LDJ
Roche Diagnostics Corp.
Toxicology · 126d
Cleared Apr 13, 2000
BAYER PSA ASSAY
K994221 · LTJ
Bayer Corp.
Immunology · 120d
Cleared Apr 13, 2000
EX 45-BP, MODEL 330 132
K994240 · DTB
Biotronik, Inc.
Cardiovascular · 119d
Cleared Apr 12, 2000
GSI 2000 MIDDLE EAR ANALYZER
K000097 · ETY
Grason-Stadler, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 12, 2000
SOFTLINE SPRING CLIP
K000098 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 90d
Cleared Apr 12, 2000
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
K000105 · GZF
Medtronic Vascular
Neurology · 89d
Cleared Apr 12, 2000
JET PORT PLUS CATHETER SYSTEM
K000125 · LJT
Clinical Plastic Products SA
General Hospital · 85d
Cleared Apr 12, 2000
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
K000127 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 85d
Cleared Apr 12, 2000
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD...
K000275 · CAD
Datex-Ohmeda, Inc.
Anesthesiology · 72d
Cleared Apr 12, 2000
INCENTIVE SPIROMETER
K000314 · BWF
Engineered Medical Systems
Anesthesiology · 71d
Cleared Apr 12, 2000
MTP DISPOSABLE TROCAR VALVES
K000337 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 69d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000390 · LYY
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000391 · LYY
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426 · EBZ
Bisco, Inc.
Dental · 63d
Cleared Apr 12, 2000
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN &...
K000555 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 54d
Cleared Apr 12, 2000
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50...
K000584 · LYY
Shasta Asia Partners Gloves...
General Hospital · 50d
Cleared Apr 12, 2000
NITRILE EXAM GLOVE, POWDER FREE, BLUE
K000670 · LZA
Shasta Asia Partners Gloves...
General Hospital · 44d
Cleared Apr 12, 2000
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
K000688 · LZA
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 43d
Cleared Apr 12, 2000
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
K000740 · MQX
Asahi Iryoki Co., Ltd.
General Hospital · 36d
Cleared Apr 12, 2000
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K000793 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Apr 12, 2000
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
K001008 · FLL
Oriental System Technology, Inc.
General Hospital · 14d