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
112105–112128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 1993
SURGICAL RETRACTOR/BLUNT DISSECTOR
K933009 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 74d
Cleared Sep 02, 1993
CAPIOX SX HOLLOW FIBER OXYGENATOR
K922799 · DTZ
Terumo Medical Corp.
Cardiovascular · 449d
Cleared Sep 02, 1993
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
K924935 · KKY
Polyclinic Medical Center
General & Plastic Surgery · 337d
Cleared Sep 02, 1993
RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
K925505 · BTR
Rusch, Inc.
Anesthesiology · 307d
Cleared Sep 02, 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP
K925507 · BTR
Rusch, Inc.
Anesthesiology · 307d
Cleared Sep 02, 1993
RUSCH SAFETY CLEAR PLUS CUFFED W/MAGILL TIP
K925508 · BTR
Rusch, Inc.
Anesthesiology · 297d
Cleared Sep 02, 1993
HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION
K930068 · JPA
Technidyne Corp.
Hematology · 239d
Cleared Sep 02, 1993
HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY
K930235 · GGP
Technidyne Corp.
Hematology · 240d
Cleared Sep 01, 1993
AMNIOTEST(TM)
K914419 · HIO
Pro-Lab, Inc.
Chemistry · 699d
Cleared Sep 01, 1993
TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY
K922834 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 446d
Cleared Sep 01, 1993
CONDOOM SHELF LIFE -- MODIFICATIONS
K922889 · HIS
Safetex Corp.
Obstetrics & Gynecology · 467d
Cleared Sep 01, 1993
FACSORT FLOW CYTOMETER
K923790 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 400d
Cleared Sep 01, 1993
TOF-GUARD TRANSMISSION MONITOR
K925159 · KOI
Biometer Intl. A/S
Anesthesiology · 323d
Cleared Sep 01, 1993
U108, U105, G209-B
K925224 · HQY
Custom Optical Frames, Inc.
Ophthalmic · 320d
Cleared Sep 01, 1993
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · DRX
3M Health Care, Ltd.
Cardiovascular · 222d
Cleared Sep 01, 1993
PMT(R) SILICONE GEL SHEETING MODEL 3505-1
K930409 · MDA
Pmt Corp.
General & Plastic Surgery · 218d
Cleared Sep 01, 1993
BECKMAN VIGIL PLUS CONTROL
K930850 · JJY
Beckman Instruments, Inc.
Immunology · 195d
Cleared Sep 01, 1993
UNIQUET
K931198 · GAX
Icat Systems
General & Plastic Surgery · 176d
Cleared Sep 01, 1993
ABBOTT PLUM XL INFUSION PUMP
K931375 · FRN
Abbott Laboratories
General Hospital · 167d
Cleared Sep 01, 1993
STAINLESS STEEL ORTHODONTIC PRODUCTS
K931980 · DYO
Ortho Organizers, Inc.
Dental · 132d
Cleared Sep 01, 1993
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE
K932788 · DWZ
Cordis Corp.
Cardiovascular · 84d
Cleared Sep 01, 1993
CARDIMA SEEKER AND STUBBIE GUIDEWIRES
K932801 · DQX
Cardima, Inc.
Cardiovascular · 84d
Cleared Aug 31, 1993
READAR
K925951 · LRG
Alamar Biosciences Laboratory, Inc.
Microbiology · 280d
Cleared Aug 31, 1993
CYBILNATE(R) UMBILICAL CATHETER
K926097 · FOZ
Cyex Medical Technologies, Inc.
General Hospital · 271d