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
107905–107928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1994
ADULT ANESTHESIA BREATHING CIRCUIT
K942568 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 10d
Cleared Jun 10, 1994
VENTILATOR HOSE
K942569 · BZO
Med-Plastics Intl., Inc.
Anesthesiology · 10d
Cleared Jun 10, 1994
MAPLESON D CIRCUIT
K942570 · CAI
Med-Plastics Intl., Inc.
Anesthesiology · 10d
Cleared Jun 10, 1994
HYPER-INFLATION BAG
K942571 · NHK
Med-Plastics Intl., Inc.
Anesthesiology · 10d
Cleared Jun 10, 1994
VOLUME VENTILATOR
K942572 · BZO
Med-Plastics Intl., Inc.
Anesthesiology · 10d
Cleared Jun 09, 1994
K6-I DIAGNOSTIC SYSTEM
K922456 · KZM
Myo-Tronics, Inc.
Dental · 744d
Cleared Jun 09, 1994
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
K923260 · HET
Imtec Corp.
Obstetrics & Gynecology · 707d
Cleared Jun 09, 1994
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K925102 · KNT
Abbott Laboratories
Gastroenterology & Urology · 609d
Cleared Jun 09, 1994
MATRIX PRO-ELECDT
K930263 · LIH
Matrix Electromedical, Inc.
Neurology · 506d
Cleared Jun 09, 1994
STAT-TENS
K931079 · GZJ
Skylark Device Co., Ltd.
Neurology · 463d
Cleared Jun 09, 1994
P.F.C. BIPOLAR HIP SYSTEM
K931655 · KWY
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 430d
Cleared Jun 09, 1994
FLEXIFLO GASTROSTOMY KIT
K932861 · KNT
Abbott Laboratories
Gastroenterology & Urology · 363d
Cleared Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119 · FPA
Abbott Laboratories
General Hospital · 288d
Cleared Jun 09, 1994
HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR
K934288 · CBH
Neo-Tech, Inc.
Anesthesiology · 280d
Cleared Jun 09, 1994
NEXT WAVE PHYSIOACOUSTIC MATTRESS
K934886 · IRO
Next Wave, Inc.
Physical Medicine · 240d
Cleared Jun 09, 1994
HAND-HELD HEAT APPLICATOR
K935995 · ILY
Avon Products, Inc.
Physical Medicine · 176d
Cleared Jun 09, 1994
MPR-814
K940442 · IYB
Xri, Inc.
Radiology · 128d
Cleared Jun 09, 1994
K-SNAP
K940586 · DRX
Katecho, Inc.
Cardiovascular · 121d
Cleared Jun 09, 1994
WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA
K940683 · ISA
Wahl Clipper Corp.
Physical Medicine · 119d
Cleared Jun 09, 1994
WAHL(R) FOOT COMFORT MASSAGER
K940837 · IRO
Wahl Clipper Corp.
Physical Medicine · 106d
Cleared Jun 09, 1994
PRO PULSE SYRINGE IRRIGATION SYSTEM
K941385 · LJH
Giesy Consultants, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 09, 1994
DISPOSABLE ASPIRATION/IRRIGATION TRUMPET VALVE PROBE
K941390 · GCJ
Deroyal Industries, Inc.
General & Plastic Surgery · 79d
Cleared Jun 09, 1994
WAHL COMPACT COMFORT MASSAGER
K941412 · IRO
Wahl Clipper Corp.
Physical Medicine · 78d
Cleared Jun 09, 1994
DAILY WEAR SOFT CONTACT LENSES
K941484 · LPL
Ciba Vision Corporation
Ophthalmic · 73d