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
95761–95784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1996
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
K963229 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 78d
Cleared Nov 05, 1996
TPS APICAL IMPLANT
K963401 · DZE
Steri-Oss, Inc.
Dental · 68d
Cleared Nov 05, 1996
REUSABLE TROCAR WITH SLEEVE (COMMON)
K963815 · GCJ
Pilling Weck Group
General & Plastic Surgery · 43d
Cleared Nov 05, 1996
BISFIL 2B
K964000 · KLE
Bisco, Inc.
Dental · 29d
Cleared Nov 05, 1996
NEEDLE, ACUPUNCTURE
K964051 · MQX
S-Tcm Enterprises, Inc.
General Hospital · 27d
Cleared Nov 05, 1996
GLUMA CONDITIONER
K964140 · KLE
Heraeus Kulzer, Inc.
Dental · 21d
Cleared Nov 04, 1996
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE...
K955122 · DTB
Intermedics, Inc.
Cardiovascular · 361d
Cleared Nov 04, 1996
BOOSTER LITE 3 MOTORIZED SCOOTER
K955274 · INI
Optimed Technologies, Inc.
Physical Medicine · 355d
Cleared Nov 04, 1996
BOOSTER TROPHY 5 MOTORIZED SCOOTER
K955275 · INI
Optimed Technologies, Inc.
Physical Medicine · 355d
Cleared Nov 04, 1996
BOOSTER LITE 4 MOTORIZED SCOOTER
K955276 · INI
Optimed Technologies, Inc.
Physical Medicine · 355d
Cleared Nov 04, 1996
LIFEPAK 500
K955854 · MKJ
Physio-Control Corp.
Cardiovascular · 312d
Cleared Nov 04, 1996
MICROFERRET CATHETER
K961668 · KRA
Cook, Inc.
Cardiovascular · 188d
Cleared Nov 04, 1996
FLEXILOG LS 13921
K961895 · KLA
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 172d
Cleared Nov 04, 1996
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
K962584 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 126d
Cleared Nov 04, 1996
VEGA HEMATOLOGY ANALYZER
K962633 · GKZ
Abx, Inc.
Hematology · 122d
Cleared Nov 04, 1996
AMR-ACV CLAMPS
K962668 · DXC
Applied Medical Resources
Cardiovascular · 118d
Cleared Nov 04, 1996
E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON...
K962690 · GEI
Valleylab, Inc.
General & Plastic Surgery · 116d
Cleared Nov 04, 1996
EZ-FIX SMALL CANNULATED SCREW SYSTEM
K962987 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 95d
Cleared Nov 04, 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · DHR
Beckman Instruments, Inc.
Immunology · 90d
Cleared Nov 04, 1996
HEELBO SECURITY BELT
K963060 · FMQ
Heelbo, Inc.
General Hospital · 89d
Cleared Nov 04, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K963061 · DCK
Beckman Instruments, Inc.
Immunology · 89d
Cleared Nov 04, 1996
TRUPEAK PEAK FLOW METER
K963095 · BZH
Monaghan Medical Corp.
Anesthesiology · 88d
Cleared Nov 04, 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930...
K963187 · DSP
Boston Scientific Corp
Cardiovascular · 82d
Cleared Nov 04, 1996
INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
K963402 · MBI
Innovasive Devices, Inc.
Orthopedic · 67d