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

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175,820 results
127393–127416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1990
ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD
K897127 · CAC
Atrium Medical Corp.
Anesthesiology · 77d
Cleared Mar 13, 1990
DISPOSABLE CO2 ABSORBER/E
K897171 · CBL
Gibeck, Inc.
Anesthesiology · 75d
Cleared Mar 13, 1990
MODIFIED GORE-TEX SURGICAL TAPE
K900195 · MCA
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 61d
Cleared Mar 13, 1990
RAPID NF SYSTEM
K900517 · JSW
Innovative Diagnostic Systems, Inc.
Microbiology · 39d
Cleared Mar 13, 1990
CONSTANT CURRENT STIMULATOR MODEL 022101
K900553 · JOQ
Ep Technologies, Inc.
Cardiovascular · 35d
Cleared Mar 13, 1990
'CONDUCTOR' DISPOSABLE TENS ELECTRODE
K900606 · GXY
Medical Science Products, Inc.
Neurology · 33d
Cleared Mar 13, 1990
TOMOSCAN STEREOTAXIS SIMULATION SOFTWARE
K900660 · JAK
Philips Medical Systems North...
Radiology · 32d
Cleared Mar 13, 1990
REMOTE CONTROL SWITCH
K900969 · IQA
Baylor Biomedical Services
Physical Medicine · 11d
Cleared Mar 13, 1990
K-STERILE TENS ELECTRODES
K900997 · GXY
Katecho, Inc.
Neurology · 11d
Cleared Mar 13, 1990
ENVIRONMENTAL CONTROL UNIT MODEL 7000
K901028 · IQA
Baylor Biomedical Services
Physical Medicine · 7d
Cleared Mar 13, 1990
YES-NO VOICE BOX 7011
K901029 · ILQ
Baylor Biomedical Services
Physical Medicine · 7d
Cleared Mar 13, 1990
ROTARY COMMUNICATION SCANNER MODEL 7010
K901030 · ILQ
Baylor Biomedical Services
Physical Medicine · 7d
Cleared Mar 12, 1990
MODIFIED 225/SIMV VOLUME VENTILATOR
K884389 · CBK
Monaghan Medical Corp.
Anesthesiology · 510d
Cleared Mar 12, 1990
Q-PORT SYSTEM KIT
K894650 · LJT
Quinton, Inc.
General Hospital · 231d
Cleared Mar 12, 1990
INTRAVASCULAR IMAGING SYSTEM
K895159 · LYK
Intertherapy, Inc.
Cardiovascular · 201d
Cleared Mar 12, 1990
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
K895915 · MCB
Meridian Diagnostics, Inc.
Microbiology · 153d
Cleared Mar 12, 1990
INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
K896923 · CAF
Intertech Resources, Inc.
Anesthesiology · 90d
Cleared Mar 12, 1990
HOOD SPEAKING VALVE
K897059 · JOH
Hood Laboratories
Anesthesiology · 84d
Cleared Mar 12, 1990
POLY G PHYSIOLOGICAL DATA RECORDER
K897107 · BXO
Cns, Inc.
Anesthesiology · 81d
Cleared Mar 12, 1990
LASER IMAGING WORK STATION
K897186 · HJI
Innovision Medical, Inc.
Ophthalmic · 74d
Cleared Mar 12, 1990
NIKON MULTI-SPORT SUNGLASSES
K900090 · HQY
Oculus America
Ophthalmic · 66d
Cleared Mar 12, 1990
MOBILIMB W1 WRIST CPM UNIT
K900466 · BXB
Toronto Medical Corp.
Physical Medicine · 40d
Cleared Mar 12, 1990
MODIFIED COATRON II AND COATRON JR.
K900506 · JPA
Astral Medical Systems
Hematology · 38d
Cleared Mar 12, 1990
MOBILIMB L4 LOWER LIMB CPM UNIT
K900795 · BXB
Toronto Medical Corp.
Physical Medicine · 20d