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
132769–132792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1989
UNIVERSAL ABC CONTROLER
K883580 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 140d
Cleared Jan 09, 1989
SAMPLE IDENTIFICATION STATION MODEL 38010
K884269 · JJJ
Icn Micromedic Systems
Chemistry · 90d
Cleared Jan 09, 1989
J-TIP INJECTOR SYSTEM
K884293 · KZE
California Medical Innovations, Inc.
General Hospital · 89d
Cleared Jan 09, 1989
GAUZE BANDAGE 2 X 6 YDS.
K884333 · NAB
North Health Care
General & Plastic Surgery · 87d
Cleared Jan 09, 1989
GAUZE BANDAGE 1 X 6 YDS.
K884334 · NAB
North Health Care
General & Plastic Surgery · 87d
Cleared Jan 09, 1989
GAUZE BANDAGE 4 X 6 YDS.
K884335 · NAB
North Health Care
General & Plastic Surgery · 87d
Cleared Jan 09, 1989
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · FMG
Ohmeda Medical
General Hospital · 77d
Cleared Jan 09, 1989
LATEX SURGICAL GLOVES
K884499 · KGO
Yuli Corp., Inc.
General Hospital · 75d
Cleared Jan 09, 1989
OXYMATIC-24
K884562 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 70d
Cleared Jan 09, 1989
MTD HEDREST
K884847 · IWY
Composites Horizons, Inc.
Radiology · 49d
Cleared Jan 09, 1989
HOUVA II UVA
K885025 · FTC
National Biological Corp.
General & Plastic Surgery · 35d
Cleared Jan 09, 1989
COAT-A-COUNT METHAMPHETAMIN #TKMA1
K885071 · LAF
Diagnostic Products Corp.
Toxicology · 32d
Cleared Jan 09, 1989
KIT PAK SUCTION CATHETER KIT
K885131 · BSY
Kit Pak, Inc.
Anesthesiology · 28d
Cleared Jan 09, 1989
SHAW SUN SYSTEMS MODEL 2400
K885184 · FTC
Shaw Sun Systems
General & Plastic Surgery · 27d
Cleared Jan 06, 1989
LATEX SURGICAL GLOVE
K881664 · KGO
Lien Chang Rubber Industrial Co., Ltd.
General Hospital · 263d
Cleared Jan 06, 1989
BARD(R) ASPIRATION BIOPSY SYSTEM
K883469 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 144d
Cleared Jan 06, 1989
MMAC II TONOMETER
K884012 · HKX
Professional Technologies Corp.
Ophthalmic · 106d
Cleared Jan 06, 1989
MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676 · IZH
Elscint, Inc.
Radiology · 59d
Cleared Jan 06, 1989
MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884677 · IZH
Elscint, Inc.
Radiology · 59d
Cleared Jan 06, 1989
ADDITIONAL ELECTROSURGICAL GROUND PADS
K885172 · GEI
Conmedcorp
General & Plastic Surgery · 24d
Cleared Jan 05, 1989
ASK-300
K882977 · DQR
Medical Repackers Co.
Cardiovascular · 174d
Cleared Jan 05, 1989
UNNA BOOT DRESSING W/CALAMINE
K883224 · FRO
Graham-Field, Inc.
General & Plastic Surgery · 160d
Cleared Jan 05, 1989
GY-RO SAFE
K883785 · HOG
Gy-Ro Industry, Inc.
Ophthalmic · 120d
Cleared Jan 05, 1989
BICAP ABLATING FORCEPS BAF-7
K884306 · KNS
Circon Acmi
Gastroenterology & Urology · 84d