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
118561–118584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1992
PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS
K914438 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 90d
Cleared Jan 02, 1992
QUALICHECK 4
K915399 · JJS
Radiometer America, Inc.
Chemistry · 34d
Cleared Dec 31, 1991
PTI INTRA-ART (TM) PICK-UP WICKS
K905068 · EFQ
Pioneering Technologies, Inc.
General & Plastic Surgery · 417d
Cleared Dec 31, 1991
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665 · DRT
Ge Medical Systems Information...
Cardiovascular · 323d
Cleared Dec 31, 1991
CHEM-SLEEVE B
K912257 · KME
Haz-Med, Inc.
General Hospital · 223d
Cleared Dec 31, 1991
SONICAID TEAM
K912639 · HGM
Oxford Medilog, Inc.
Obstetrics & Gynecology · 200d
Cleared Dec 31, 1991
SIRIUS
K912813 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 194d
Cleared Dec 31, 1991
STOPCOCK
K913560 · FMG
Graham Medical Products
General Hospital · 144d
Cleared Dec 31, 1991
CORONET 100
K913785 · GWJ
Micro-Shev , Ltd.
Neurology · 130d
Cleared Dec 31, 1991
UNIVERSAL TERMINAL CAP, 3.2MM
K913919 · KFJ
Telectronics Pacing Systems, Inc.
Cardiovascular · 119d
Cleared Dec 31, 1991
PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION)
K914407 · HQY
Promedex, Inc.
Ophthalmic · 90d
Cleared Dec 31, 1991
SPECTACLE FRAMES
K914413 · HQZ
Mikado Ca.
Ophthalmic · 89d
Cleared Dec 31, 1991
PYRAMID SUNGLASSES/READING GLASSES
K914425 · HQY
Pyramid
Ophthalmic · 89d
Cleared Dec 31, 1991
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K914500 · LIT
Vas-Cath, Inc.
Cardiovascular · 84d
Cleared Dec 31, 1991
THERASTIM
K914813 · GZJ
Precision Electronics , Ltd.
Neurology · 67d
Cleared Dec 31, 1991
QUICKSTART UREA NITROGEN
K914903 · CDN
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Dec 31, 1991
GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST
K914913 · GDJ
Ideal Medical, Inc.
General & Plastic Surgery · 60d
Cleared Dec 30, 1991
PERCUDISC(TM) SYSTEM
K910823 · GEX
Percudisc, Inc.
General & Plastic Surgery · 307d
Cleared Dec 30, 1991
RAPI-JECT(R) SYRINGE
K911440 · FMF
David Bull Laboratories, USA, Inc.
General Hospital · 273d
Cleared Dec 30, 1991
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
K911599 · LSR
General Biometrics, Inc.
Microbiology · 265d
Cleared Dec 30, 1991
S-ROM ZT HA PROXIMAL FEMORAL SLEEVE
K912713 · MEH
Joint Medical Products Corp.
Orthopedic · 193d
Cleared Dec 30, 1991
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)
K912740 · HLQ
Visionary Systems, Inc.
Ophthalmic · 192d
Cleared Dec 30, 1991
MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD
K912780 · GEI
Electroscope, Inc.
General & Plastic Surgery · 189d
Cleared Dec 30, 1991
ELECTROSHIELD
K912781 · GEI
Electroscope, Inc.
General & Plastic Surgery · 189d