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
121921–121944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
K910107 · DTZ
Baxter Healthcare Corp
Cardiovascular · 90d
Cleared Apr 10, 1991
LOW VISION ENHANCEMENT SYSTEM (LVES)
K910124 · HPG
Triangle Investments
Ophthalmic · 89d
Cleared Apr 10, 1991
OPTICAL FRAME
K910179 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 85d
Cleared Apr 10, 1991
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707 · HOZ
Jedmed Instrument Co.
Ophthalmic · 49d
Cleared Apr 09, 1991
OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
K904843 · CBR
Dalton Instrument Corp.
Anesthesiology · 166d
Cleared Apr 09, 1991
HAEMODIALYSIS CONCENTRATE
K904946 · KPO
Bdh, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1991
BARD(R) SYRINGE ASSIST IRRIGATION
K905102 · OCX
C.R. Bard, Inc.
Gastroenterology & Urology · 147d
Cleared Apr 09, 1991
FORMASURE TEST REAGENT
K905217 · LIF
Di-Chem, Inc.
Gastroenterology & Urology · 140d
Cleared Apr 09, 1991
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
K905288 · BYG
Med-Tek Innovations, Inc.
Anesthesiology · 134d
Cleared Apr 09, 1991
VARIOUS TYPES OF STETHOSCOPES
K905487 · LDE
Liaoning-Usa Corp.
Cardiovascular · 124d
Cleared Apr 09, 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
K905505 · FAD
Vas-Cath, Inc.
Gastroenterology & Urology · 137d
Cleared Apr 09, 1991
MODEL FT40 TRANSONIC(TM) HEARING AID
K905516 · ESD
Sonovation, Inc. Dba Avr Sonovation
Ear, Nose, Throat · 123d
Cleared Apr 09, 1991
OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE
K910114 · GEX
Xintec Corporation
General & Plastic Surgery · 89d
Cleared Apr 09, 1991
USCI ILLUMEN-8 8F PTCA GUIDING CATHETER
K910154 · DOY
C.R. Bard, Inc.
Toxicology · 85d
Cleared Apr 09, 1991
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
K910215 · FKP
Cd Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 09, 1991
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · KDI
Minntech Corp.
Gastroenterology & Urology · 81d
Cleared Apr 09, 1991
MICROTEST MULTI MICROBE MEDIUM
K910526 · JSM
Microtest
Microbiology · 61d
Cleared Apr 09, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)
K910548 · LZO
Turnkey Intergration USA, Inc.
Orthopedic · 61d
Cleared Apr 09, 1991
MODEL 5866-46 SLEEVE KIT
K910568 · DTP
Medtronic Vascular
Cardiovascular · 57d
Cleared Apr 09, 1991
YSI PRECISION 4000 THERMOMETER
K910718 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 48d
Cleared Apr 09, 1991
BCD ADVANCED
K910923 · DTR
Shiley, Inc.
Cardiovascular · 35d
Cleared Apr 09, 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · LIT
Boston Scientific Corp
Cardiovascular · 39d
Cleared Apr 09, 1991
OPTI-PLAST 5F PTA CATHETERS
K910996 · LIT
Vas-Cath, Inc.
Cardiovascular · 36d
Cleared Apr 09, 1991
TEGWIRE (TM)
K911203 · LIT
Boston Scientific Corp
Cardiovascular · 21d