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
113641–113664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1993
PHILIPS GYROVIEW HR - RELEASE 2
K923944 · LNH
Philips Medical Systems North...
Radiology · 265d
Cleared Apr 27, 1993
TUFF TIES
K924140 · ECI
Glenroe Technologies
Dental · 252d
Cleared Apr 27, 1993
MRT-50A SUPER
K924808 · LNH
Toshiba America Mri, Inc.
Radiology · 215d
Cleared Apr 27, 1993
ENDOTRAK SYSTEM
K925083 · HRX
Instratek, Inc.
Orthopedic · 202d
Cleared Apr 27, 1993
ACS APCT REAGENT, MODIFIED
K926012 · GFO
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Apr 27, 1993
FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A
K926064 · JAA
Scientific Technology , Ltd.
Radiology · 147d
Cleared Apr 27, 1993
MRT-150A, QD SPINE COIL
K926171 · LNH
Toshiba America Mri, Inc.
Radiology · 140d
Cleared Apr 27, 1993
SPHINCTEROTOME
K930022 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 112d
Cleared Apr 27, 1993
KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE
K930219 · BSO
Kendall Healthcare Products Co....
Anesthesiology · 102d
Cleared Apr 27, 1993
RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER
K930230 · IXY
American Medical Sales, Inc.
Radiology · 98d
Cleared Apr 27, 1993
BC/WT/PF
K930249 · IXY
Tingle X-Ray Products, Inc.
Radiology · 98d
Cleared Apr 27, 1993
ORTHOCEPH OC100
K930338 · EHD
Instrumentarium Corp.
Radiology · 92d
Cleared Apr 27, 1993
RADMAN IMAGE MANAGMENT SYSTEM
K930350 · LMD
Infocure Systems, Inc.
Radiology · 92d
Cleared Apr 27, 1993
MORTARA INSTRUMENT, INC. E-SCRIBE
K930558 · DPS
Mortara Instrument, Inc.
Cardiovascular · 83d
Cleared Apr 27, 1993
DISPENS-O-DISC CLARITHROMYCIN 15 MG.
K930911 · JTN
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Apr 27, 1993
COAG-CONTROL
K930923 · GGC
American Bioproducts Co.
Hematology · 63d
Cleared Apr 27, 1993
ENDOPATH TISSUE EXTRACTION CANNULA
K930935 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 63d
Cleared Apr 27, 1993
DISPENS-O-DISC CEFPODOXIME 10 MCG.
K930946 · JTN
Difco Laboratories, Inc.
Microbiology · 63d
Cleared Apr 27, 1993
USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100
K930985 · DIO
U.S. Drug Testing, Inc.
Toxicology · 61d
Cleared Apr 27, 1993
TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067
K931247 · DAH
Helena Laboratories
Immunology · 47d
Cleared Apr 26, 1993
PREP SHAVE KIT (NON-STERILE)
K925016 · LRO
Customed, Inc.
General & Plastic Surgery · 214d
Cleared Apr 26, 1993
SURGICAL TRAY (STERILE)
K925022 · LRD
Customed, Inc.
Ear, Nose, Throat · 214d
Cleared Apr 23, 1993
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736 · FPB
Abbott Laboratories
General Hospital · 429d
Cleared Apr 23, 1993
OHIO INFANT WARMER SYSTEM
K921766 · FMT
Ohmeda Medical
General Hospital · 374d