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
88969–88992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1998
SMC 28MM CERAMIC FEMORAL HEADS
K981302 · LZO
Signal Medical Corp.
Orthopedic · 77d
Cleared Jun 25, 1998
ORTHODONTIC BRACES
K981433 · DYW
Midwest Orthodontic Mfg.
Dental · 66d
Cleared Jun 25, 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443 · JHI
Princeton BioMeditech Corp.
Chemistry · 64d
Cleared Jun 25, 1998
GC FUJI ORTHO LC
K981461 · DYH
GC America, Inc.
Dental · 63d
Cleared Jun 25, 1998
CHOL
K981476 · CHH
Abbott Laboratories
Chemistry · 62d
Cleared Jun 25, 1998
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE...
K981506 · LKY
Repro-Med Systems, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 25, 1998
CARESIDE URIC ACID
K981604 · KNK
Careside, Inc.
Chemistry · 58d
Cleared Jun 25, 1998
CARESIDE ANALYZER
K981610 · CEO
Careside, Inc.
Chemistry · 56d
Cleared Jun 25, 1998
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
K981838 · JHI
Unotech Diagnostics, Inc.
Chemistry · 30d
Cleared Jun 25, 1998
SPENCO SILICONE GEL SHEET
K981902 · MDA
Spenco Medical Corp.
General & Plastic Surgery · 24d
Cleared Jun 25, 1998
POLYSORB SUTURE
K981935 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 23d
Cleared Jun 25, 1998
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K982009 · EIA
Scitech Solutions, Inc.
Dental · 84d
Cleared Jun 25, 1998
WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
K982097 · FMI
Worldwide Medical Technologies, LLC
General Hospital · 10d
Cleared Jun 24, 1998
SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
K974417 · MNS
ResMed Corp
Anesthesiology · 212d
Cleared Jun 24, 1998
SEMKIN INSULATED BIPOLAR FORCEP
K974593 · HTD
Titan Mfg., Inc.
General & Plastic Surgery · 197d
Cleared Jun 24, 1998
SEMKIN BIPOLAR FORCEP
K974594 · HTD
Titan Mfg., Inc.
General & Plastic Surgery · 197d
Cleared Jun 24, 1998
CUSHING BAYONET, INSULATED BIPOLAR FORCEP
K974595 · HTD
Titan Mfg., Inc.
General & Plastic Surgery · 197d
Cleared Jun 24, 1998
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL
K974735 · JOS
Aaron Medical Industries
General & Plastic Surgery · 188d
Cleared Jun 24, 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
K980591 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 127d
Cleared Jun 24, 1998
UNIVERSAL DRIVE SYSTEM
K981269 · HRX
Linvatec Corp.
Orthopedic · 78d
Cleared Jun 24, 1998
MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
K981416 · GEI
Magna Advanced Technologies, Inc.
General & Plastic Surgery · 65d
Cleared Jun 24, 1998
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K981779 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 35d
Cleared Jun 24, 1998
DRS SYSTEM
K981822 · ITH
Professional Distribution Systems, Inc.
Physical Medicine · 33d
Cleared Jun 24, 1998
OLYMPUS CALCIUM ARSENAZO III REAGENT
K982035 · CJY
Olympus Diagnostica GmbH
Chemistry · 14d