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
98089–98112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1996
RDI CARDIAC INSULATION PAD
K960312 · DWP
R D Intl.
Cardiovascular · 88d
Cleared Apr 19, 1996
HEBELER SAFE-T-TUBE
K960450 · BTR
Boston Medical Products, Inc.
Anesthesiology · 80d
Cleared Apr 19, 1996
CRP-LATEX SEIKEN XR REAGENT SYSTEM
K960702 · DCK
Globe Management Support, Inc.
Immunology · 59d
Cleared Apr 19, 1996
RF-LATEX SEIKEN REAGENT SYSTEM
K960703 · DHR
Globe Management Support, Inc.
Immunology · 59d
Cleared Apr 19, 1996
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
K960949 · KNX
Bristol-Myers Squibb
Gastroenterology & Urology · 39d
Cleared Apr 19, 1996
THE MAGNUM CHIN IMPLANT
K961071 · FWP
Rand Scientific Corp.
General & Plastic Surgery · 32d
Cleared Apr 19, 1996
PEC IMPLANT
K961072 · MIC
Rand Scientific Corp.
General & Plastic Surgery · 32d
Cleared Apr 19, 1996
MEDIAL MALAR IMPLANT
K961080 · LZK
Rand Scientific Corp.
General & Plastic Surgery · 32d
Cleared Apr 19, 1996
THE NAUTILUS
K961124 · FZE
Rand Scientific Corp.
General & Plastic Surgery · 29d
Cleared Apr 18, 1996
DRS 4 DIALYZER REPROCESSING SYSTEM
K931336 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 1129d
Cleared Apr 18, 1996
UNIVEC NON-REUSABLE SYRINGE
K933469 · MEG
Univec, Inc.
General Hospital · 1007d
Cleared Apr 18, 1996
MOLLOY INTUBATING STYLETTE
K943104 · BSR
Molloy Corp.
Anesthesiology · 659d
Cleared Apr 18, 1996
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
K950688 · DRT
Safety Tek Corp.
Cardiovascular · 429d
Cleared Apr 18, 1996
WHITE RIVER BATTERY-POWERED BREAST PUMP
K952712 · HGX
Natural Technologies, Inc.
Ophthalmic · 309d
Cleared Apr 18, 1996
SURGICAL APPAREL
K954549 · FYC
Global Healthcare, Inc.
General Hospital · 199d
Cleared Apr 18, 1996
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
K954814 · LJM
Orgentec
Immunology · 182d
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
K954815 · LJM
Orgentec
Immunology · 182d
Cleared Apr 18, 1996
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
K954829 · LJM
Orgentec
Immunology · 181d
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
K954832 · LJM
Orgentec
Immunology · 181d
Cleared Apr 18, 1996
ENDOSCOPE INTRODUCER KIT
K955717 · FDE
Mitsubishi Cable America, Inc.
Gastroenterology & Urology · 122d
Cleared Apr 18, 1996
IMMUNOCARD TOXIN A
K955859 · LLH
Meridian Diagnostics, Inc.
Microbiology · 113d
Cleared Apr 18, 1996
PERINEOMETER
K960311 · HIR
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 18, 1996
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K960353 · LYC
Ceramed Corp.
Dental · 84d
Cleared Apr 18, 1996
OSTEOGRAFT/N-700 HYDROXYLAPTITE
K960368 · LYC
Ceramed Corp.
Dental · 84d