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
135553–135576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1988
BIO-EMG MODEL 800
K873947 · KZM
Bio-Research Associates, Inc.
Dental · 212d
Cleared Apr 27, 1988
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
K874084 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 203d
Cleared Apr 27, 1988
PERIODONTAL PROBE - AUTOPROBE
K880209 · EIL
Dentsply Intl.
Dental · 103d
Cleared Apr 27, 1988
DACOMED CYSTOMETER
K880391 · EXQ
Dacomed Corp.
Gastroenterology & Urology · 89d
Cleared Apr 27, 1988
ENZYGNOST(R) TAT REAGENTS
K880700 · JBQ
Behring Diagnostics, Inc.
Hematology · 65d
Cleared Apr 27, 1988
LX-100 SLIDE STAINER
K880745 · KPA
Innovative Medical Systems, Inc.
Hematology · 63d
Cleared Apr 27, 1988
UMBILICAL CORD CLAMP
K880753 · HFW
I M, Inc.
Obstetrics & Gynecology · 62d
Cleared Apr 27, 1988
LIFEGUARD BACTERIAL AND VIRAL FILTER
K880958 · CAH
Lifeguard Medical Products, Inc.
General Hospital · 51d
Cleared Apr 27, 1988
7.5 MHZ ENDORECTAL PROBE
K881028 · IYO
Philips Ultrasound, Inc.
Radiology · 48d
Cleared Apr 27, 1988
VAPOR-PHASE HEATED WIRE CONTROLLER
K881137 · BZE
Advanced Research Technologies, Inc.
Anesthesiology · 42d
Cleared Apr 27, 1988
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
K881290 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 27, 1988
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
K881332 · OCZ
Baxter Healthcare Corp
Gastroenterology & Urology · 29d
Cleared Apr 27, 1988
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · LJP
Ortho Diagnostic Systems, Inc.
Microbiology · 16d
Cleared Apr 27, 1988
BREWER GEL FOR CAMPYLOBACTER
K881502 · KZJ
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 16d
Cleared Apr 27, 1988
A2J MZ 45 LASER LIGHT FOR POSITIONING
K881591 · IWX
A2j, Inc.
Radiology · 14d
Cleared Apr 27, 1988
ACROMED WASHERS
K881699 · HTN
Buckman Co., Inc.
Orthopedic · 8d
Cleared Apr 26, 1988
PRECISION SPINAL ADJUSTER MODEL 115
K870910 · LXM
Kinetic Technology, Inc.
Physical Medicine · 418d
Cleared Apr 26, 1988
LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.
K880305 · LJT
Strato Medical Corp.
General Hospital · 92d
Cleared Apr 26, 1988
LYME DISEASE ELISA
K880476 · LSR
Hillcrest Biologicals
Microbiology · 82d
Cleared Apr 25, 1988
FRESENIUS PURISTERIL 340 (TM)
K874573 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 172d
Cleared Apr 25, 1988
TC2-64B TRANSCRANIAL DOPPLER
K874684 · IYO
Carolina Medical Electronics
Radiology · 165d
Cleared Apr 25, 1988
TRANS-SCAN 3-D TRANSCRANIAL DOPPLER
K874685 · IYO
Carolina Medical Electronics
Radiology · 165d
Cleared Apr 25, 1988
VIDEO ANALYZER 4000
K874750 · IBJ
Scientific Imaging, Inc.
Pathology · 159d
Cleared Apr 25, 1988
CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP
K880204 · FRN
Pharmacia Deltec, Inc.
General Hospital · 97d