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
111145–111168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1993
ADJUSTABLE BED
K930703 · FNL
Maxwell Products, Inc.
General Hospital · 285d
Cleared Nov 22, 1993
PHOTOPHONE MULTIVIEW
K931186 · LMD
Image Data Corp.
Radiology · 258d
Cleared Nov 22, 1993
1.5T EDGE AND 1.0T VISTA SYSTEMS
K931544 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 238d
Cleared Nov 22, 1993
AESOP (AUTOMATED ENDOSCOPIC SYSTEM FOR OPTIMAL POS
K931783 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 227d
Cleared Nov 22, 1993
ROTA SYSTEM XL
K931839 · HMF
Rota Systems Medfurniture, Inc.
Ophthalmic · 223d
Cleared Nov 22, 1993
CEMAX VIPSTATION(TM) AND/OR SOFTWARE
K932372 · LLZ
Cemax, Inc.
Radiology · 192d
Cleared Nov 22, 1993
PHX TECHNOLOGIES CORP ELECTROSURGICAL PROBES
K932392 · GEI
Phx Technologies Corp.
General & Plastic Surgery · 188d
Cleared Nov 22, 1993
NIDEK MODEL AC-2300
K932836 · HQF
Nidek, Inc.
Ophthalmic · 164d
Cleared Nov 22, 1993
PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS
K933247 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 143d
Cleared Nov 22, 1993
TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
K933475 · GKZ
Miles, Inc.
Hematology · 129d
Cleared Nov 22, 1993
TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
K933478 · GKZ
Miles, Inc.
Hematology · 129d
Cleared Nov 22, 1993
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER
K933536 · GCJ
Neimark Labs, Inc.
General & Plastic Surgery · 125d
Cleared Nov 22, 1993
MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL
K933659 · LNH
Medic, Inc.
Radiology · 118d
Cleared Nov 22, 1993
E-SP COMBINED EPIDURAL-SPINAL ANESTHESIA TRAY
K933711 · CAZ
Neurodelivery Technology, Inc.
Anesthesiology · 115d
Cleared Nov 22, 1993
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
K933715 · GEX
Boston Scientific Corp
General & Plastic Surgery · 115d
Cleared Nov 22, 1993
PHILIPS ANGIOPRO RELEASE 2.1
K933791 · JAA
Philips Medical Systems North...
Radiology · 110d
Cleared Nov 22, 1993
0.5T ASSET SYSTEM
K933835 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 109d
Cleared Nov 22, 1993
PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
K933997 · GMD
Alexon Biomedical, Inc.
Microbiology · 97d
Cleared Nov 22, 1993
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · JTN
Remel Co.
Microbiology · 91d
Cleared Nov 22, 1993
R AND D BATERIES
K934683 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 53d
Cleared Nov 22, 1993
AMPHETAMINE TEST SYSTEM
K934693 · DKZ
U.S. Drug Testing, Inc.
Toxicology · 53d
Cleared Nov 22, 1993
OPUS NAPA
K934705 · LAN
Pb Diagnostic Systems, Inc.
Toxicology · 53d
Cleared Nov 22, 1993
ARGELITE W
K934769 · EJT
Argen Precious Metals, Inc.
Dental · 48d
Cleared Nov 22, 1993
NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS
K934850 · KPX
Victoreen, Inc.
Radiology · 41d