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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
113785–113808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1993
POWER PACK 350/BATTERY PACK 351
K923992 · CBK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 246d
Cleared Apr 13, 1993
CELL COLLECTING BRUSH
K924908 · HHT
Anderson Winn Paper Co.
Obstetrics & Gynecology · 195d
Cleared Apr 13, 1993
CASSETTE, RADIOGRAPHIC FILM
K930220 · IXA
X-Ray Accessories Mfg. Co.
Radiology · 88d
Cleared Apr 13, 1993
CKMB ISOENZYME CONTROL-LEVEL 1,2.3
K930873 · JJT
Cala Diagnostics
Chemistry · 53d
Cleared Apr 13, 1993
CKMB CONTROL - LEVEL 1,2,3
K930875 · JJT
Cala Diagnostics
Chemistry · 53d
Cleared Apr 12, 1993
MULTIPURPOSE RESIN CEMENT
K923473 · EMA
Dentsply Intl.
Dental · 272d
Cleared Apr 12, 1993
DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES
K925358 · LYY
Colonial Surgical Supply, Inc.
General Hospital · 172d
Cleared Apr 12, 1993
IL TEST(TM) PROTEIN S
K930327 · GGP
Instrumentation Laboratory CO
Hematology · 80d
Cleared Apr 12, 1993
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
K930359 · JHT
Helena Laboratories
Chemistry · 76d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-GC
K930998 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-AI
K930999 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 12, 1993
SIEMENS MODEL 584-P-AI-D
K931000 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 45d
Cleared Apr 09, 1993
VITALMAX 840 SERIES
K914164 · BXN
Pace Tech Medical Monitors, Inc.
Anesthesiology · 570d
Cleared Apr 09, 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590 · BZD
Puritan Bennett Corp.
Anesthesiology · 263d
Cleared Apr 09, 1993
BENSON CCA100
K924652 · EWG
Benson Medical Instruments Co.
Ear, Nose, Throat · 206d
Cleared Apr 09, 1993
9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
K930134 · DPS
S & W Medico Teknik
Cardiovascular · 87d
Cleared Apr 08, 1993
SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM
K904380 · MIA
Custom Medical Concepts, Inc.
Anesthesiology · 925d
Cleared Apr 08, 1993
OHMEDA 7800 ANESTHESIA VENTILATOR
K913791 · BSZ
Ohmeda Anesthesia Systems Therapy Group
Anesthesiology · 594d
Cleared Apr 08, 1993
KERAMAIL
K915653 · EIH
Wilde-USA, Inc.
Dental · 477d
Cleared Apr 08, 1993
TOOTH CONDITIONER
K920843 · KZP
Confi-Dental Products Co.
Dental · 408d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · LKQ
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582 · LFZ
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Apr 08, 1993
PHYSIO-DYNE EASI - LAB
K922660 · BZL
Physio-Dyne
Anesthesiology · 309d
Cleared Apr 08, 1993
THREE SPIKE CUP
K922870 · GRF
Osteo Technology, Inc.
Microbiology · 308d