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
120217–120240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1991
GENOX MODEL CT-1
K904639 · CAW
Pacific Consolidated Industries
Anesthesiology · 306d
Cleared Aug 13, 1991
TOPS NEEDLE TIP PROBE & PVC TIP PROBE
K910453 · CCE
Baxter Healthcare Corp
Anesthesiology · 193d
Cleared Aug 13, 1991
PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST
K911656 · CAC
Pfizer Hospital Products Group, Inc.
Anesthesiology · 123d
Cleared Aug 13, 1991
LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)
K911763 · DPW
Vasamedics, LLC
Cardiovascular · 116d
Cleared Aug 13, 1991
LUXUS 132 ND: YAG SURGICAL LASER SYSTEM
K911987 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 99d
Cleared Aug 13, 1991
ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER
K912029 · GEX
Coherent Medical Group
General & Plastic Surgery · 98d
Cleared Aug 13, 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
K912147 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Aug 13, 1991
PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE
K912171 · EJF
Jack James
Dental · 89d
Cleared Aug 13, 1991
DSL BETA 2 MICROGLOBULIN (DSL 6100)
K912173 · JZG
Diagnostic Systems Laboratories, Inc.
Immunology · 89d
Cleared Aug 13, 1991
COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM
K912410 · LNH
Reality Imaging Corp.
Radiology · 74d
Cleared Aug 13, 1991
FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC
K912767 · EQH
Microaire Advanced Surgical Products
Ear, Nose, Throat · 50d
Cleared Aug 13, 1991
DASH IV
K912929 · DSF
Astro-Med, Inc.
Cardiovascular · 39d
Cleared Aug 13, 1991
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K912984 · LIT
Vas-Cath, Inc.
Cardiovascular · 46d
Cleared Aug 13, 1991
DENTA SAFE(TM) LATEX EXAMINATION GLOVES
K912999 · LYY
Dental Care Intl., Inc.
General Hospital · 36d
Cleared Aug 12, 1991
BRAIDED HIGH PRESSURE CATHETER CONNECTOR
K905415 · FOZ
The R Group
General Hospital · 251d
Cleared Aug 12, 1991
SLIDEX MENINGITE-KIT 5
K910210 · GTJ
Vitek Systems, Inc.
Microbiology · 209d
Cleared Aug 12, 1991
TRANSDUCER PROTECTOR
K910821 · FIB
Gelman Sciences, Inc.
Gastroenterology & Urology · 167d
Cleared Aug 12, 1991
DUNLAP HEAT PAD
K911195 · IRT
Home Healthcare Products, Inc.
Physical Medicine · 147d
Cleared Aug 12, 1991
DIALYSIS TRANDSDUCER PROTECTOR
K911658 · FIB
Tico Medical Instruments, Inc.
Gastroenterology & Urology · 122d
Cleared Aug 12, 1991
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · DTN
Medtronic Vascular
Cardiovascular · 112d
Cleared Aug 12, 1991
OPUS(R) ROZO
K911834 · LGD
Pb Diagnostic Systems, Inc.
Immunology · 109d
Cleared Aug 12, 1991
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH
K911870 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 108d
Cleared Aug 12, 1991
PMT METAL LOCATOR, MODEL 3630-1
K911886 · HPM
Pmt Corp.
Ophthalmic · 105d
Cleared Aug 12, 1991
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA
K911903 · DHB
Pharmacia, Inc.
Immunology · 105d