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
110785–110808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1993
DRYSLIDE CEFIN
K930702 · JTN
Difco Laboratories, Inc.
Microbiology · 315d
Cleared Dec 22, 1993
HEPA 2500 AIR CLEANER
K930860 · FRF
Trion, Inc.
General Hospital · 307d
Cleared Dec 22, 1993
PERCUTANEOUS DRAINAGE LOOP CATHETER SET
K931195 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 288d
Cleared Dec 22, 1993
ENDO-JUDGE
K932591 · GAB
Synergistic Medical Technologies, Inc.
General & Plastic Surgery · 208d
Cleared Dec 22, 1993
ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA
K932664 · KGO
Smith & Nephew Perry
General Hospital · 203d
Cleared Dec 22, 1993
ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC
K932665 · KGO
Smith & Nephew Perry
General Hospital · 203d
Cleared Dec 22, 1993
CALSSIQUE OR MYSTIQUE
K932978 · KCZ
Dekumed, Kunststofftechnik Degler GmbH
General & Plastic Surgery · 188d
Cleared Dec 22, 1993
DYNAREX GAUZE SPONGE OR PADS
K933308 · EFQ
Dynarex Corp.
General & Plastic Surgery · 168d
Cleared Dec 22, 1993
GH GLOVES (POWERED)
K934047 · LYY
Grafik Hersteller Sdn Bhd
General Hospital · 125d
Cleared Dec 22, 1993
GH GLOVES (POWDER FREE)
K934048 · LYY
Grafik Hersteller Sdn Bhd
General Hospital · 125d
Cleared Dec 22, 1993
WATTS RAKE DEVICE
K934163 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 120d
Cleared Dec 22, 1993
MESALT STERILE DRESSING
K934839 · KMF
Richard Hamer Assoc., Inc.
General & Plastic Surgery · 75d
Cleared Dec 22, 1993
INSUFFLATION TUBING SET, PHX500-082
K935059 · FCX
Phx Technologies Corp.
Gastroenterology & Urology · 62d
Cleared Dec 22, 1993
OPUS DIGITOXIN
K935229 · DPG
Pb Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 22, 1993
PRO FIT-CYBER II OPTION
K935289 · ESD
Qualitone
Ear, Nose, Throat · 49d
Cleared Dec 22, 1993
CLINICAL BLOOD GAS
K935311 · BXK
Acetylene Gas Co.
Anesthesiology · 50d
Cleared Dec 21, 1993
TYSHAK PERIPHERAL BALLOON DILATION CATHETER
K931009 · LIT
NuMED, Inc.
Cardiovascular · 305d
Cleared Dec 21, 1993
NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE
K931426 · GXY
Medicotest, Inc.
Neurology · 274d
Cleared Dec 21, 1993
CUTANEOUS ELECTRODE
K931430 · GXY
Medicotest, Inc.
Neurology · 274d
Cleared Dec 21, 1993
THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM
K931594 · IOQ
Medical Device Inspection Co., Inc.
Physical Medicine · 265d
Cleared Dec 21, 1993
IN-LINE BURETTE SET
K931658 · FPA
Douglas Medical Products Corp.
General Hospital · 260d
Cleared Dec 21, 1993
CARDIMA TRACKER(R) INFUSION CATHETER
K932800 · KRA
Cardima, Inc.
Cardiovascular · 195d
Cleared Dec 21, 1993
STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM
K933091 · FNM
Creative Medical, Inc.
General Hospital · 180d
Cleared Dec 21, 1993
RUSSELL & HANCOCK 524 AND 422 SUNGLASSES
K933323 · HQY
Russell & Hancock, Ltd.
Ophthalmic · 167d