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
105529–105552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1994
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K944790 · GBZ
Applied Medical Resources
General & Plastic Surgery · 62d
Cleared Nov 29, 1994
MEDRAD COUNTERPOISE SYSTEM
K944983 · JAK
Medrad, Inc.
Radiology · 49d
Cleared Nov 29, 1994
MICROSIL
K945255 · ESD
Microsonic, Inc.
Ear, Nose, Throat · 32d
Cleared Nov 29, 1994
ABG NEEDLE PROTECTION
K945485 · CBT
Devon Industries, Inc.
Anesthesiology · 21d
Cleared Nov 29, 1994
GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y...
K945543 · CAH
Intersect Medical Products, Inc.
General Hospital · 15d
Cleared Nov 28, 1994
POSITIVE AIRWAY PRESSURE SYSTEM
K933184 · BZD
Innovative Medical Systems, Inc.
Anesthesiology · 516d
Cleared Nov 28, 1994
VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT
K933575 · GQP
Symex Corp.
Microbiology · 493d
Cleared Nov 28, 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K935921 · LZO
Smith & Nephew Richards, Inc.
Orthopedic · 376d
Cleared Nov 28, 1994
STORZ PHACO AND FRAG HANDPIECES
K935926 · HQC
Storz Instrument Co.
Ophthalmic · 350d
Cleared Nov 28, 1994
COIL POSITIONER SET
K940189 · KRD
Cook, Inc.
Cardiovascular · 319d
Cleared Nov 28, 1994
ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE
K940322 · DSA
Arbo Medical, Inc.
Cardiovascular · 308d
Cleared Nov 28, 1994
STIEGMANN-GOFF ENDOSCOPIC LIGATOR
K940661 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 286d
Cleared Nov 28, 1994
PIONEER LABORATORIES CABLE SCREW
K941866 · HWC
Pioneer Surgical Technology
Orthopedic · 224d
Cleared Nov 28, 1994
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
K942093 · GTZ
Medical Diagnostic Technologies, Inc.
Microbiology · 210d
Cleared Nov 28, 1994
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K942336 · DXN
Integrated Display Technology, Ltd.
Cardiovascular · 196d
Cleared Nov 28, 1994
SKIN NEUVEAU SCAR TREATMENT
K942339 · MDA
Puritas Health Care, Inc.
General & Plastic Surgery · 196d
Cleared Nov 28, 1994
BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550
K942683 · FRF
Bionaire Corp.
General Hospital · 174d
Cleared Nov 28, 1994
CALIBRATOR
K943012 · JIX
Prisma Systems
Toxicology · 157d
Cleared Nov 28, 1994
VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER
K943138 · MMK
Med-Safe Systems, Inc.
General Hospital · 152d
Cleared Nov 28, 1994
B-D GUARDIAN ONE PIECE SHARPS COLLECTORS
K943139 · FMI
Med-Safe Systems, Inc.
General Hospital · 152d
Cleared Nov 28, 1994
PORTA-RESP MONITOR
K943146 · CAP
S & M Instrument Co.
Anesthesiology · 151d
Cleared Nov 28, 1994
NORELCO CLEAN AIR SYSTEM
K943238 · FRF
Philips Electronic North America...
General Hospital · 145d
Cleared Nov 28, 1994
STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES
K943323 · HRX
Stryker Corp.
Orthopedic · 140d
Cleared Nov 28, 1994
ACE CEDIA CORTISOL ASSAY
K943427 · CGR
Schiapparelli Biosystems, Inc.
Chemistry · 136d