FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
133369–133392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 05, 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · DSH
Del Mar Avionics
Cardiovascular · 83d
Cleared Jan 05, 1989
MICRO-GUIDE SYSTEM
K884337 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 83d
Cleared Jan 05, 1989
ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK
K884386 · KRK
Ethitek Pharmaceuticals Co.
Cardiovascular · 79d
Cleared Jan 05, 1989
LIVING TECHNOLOGY LASER CONTACT TIPS
K884682 · GEX
Living Technology, Inc.
General & Plastic Surgery · 58d
Cleared Jan 05, 1989
MODEL 200A ELECTRONIC FORCE-SENSING PROBE
K884813 · EIL
Vine Valley Research
Dental · 49d
Cleared Jan 05, 1989
DISPOSABLE DOME STOCK #D-300
K884919 · DRS
Advanced Medical, Inc.
Cardiovascular · 38d
Cleared Jan 04, 1989
PULMO-PATTY
K882604 · BYI
Tower Stopper, Inc.
Anesthesiology · 194d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935 · LIQ
Ortho Diagnostic Systems, Inc.
Microbiology · 107d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · LIQ
Ortho Diagnostic Systems, Inc.
Microbiology · 107d
Cleared Jan 04, 1989
PERFECT CHOICE
K884245 · EJK
Challenge Products, Inc.
Dental · 85d