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
101641–101664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1995
ZEUA MYCOPLASMA
K944417 · GRZ
Zeus Scientific, Inc.
Microbiology · 329d
Cleared Aug 01, 1995
VIDEO SIGMOIDOSCOPE
K950429 · FAM
Welch Allyn, Inc.
Gastroenterology & Urology · 180d
Cleared Aug 01, 1995
IMZ - DENTAL IMPLANT SURGICAL TRAY
K951609 · DZE
Imz, GmbH
Dental · 116d
Cleared Aug 01, 1995
IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT
K951611 · DZE
Imz, GmbH
Dental · 116d
Cleared Aug 01, 1995
IMX TOXO IGG
K951636 · LGD
Abbott Laboratories
Microbiology · 116d
Cleared Aug 01, 1995
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K951961 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 97d
Cleared Aug 01, 1995
BIO-RAD URINARY 5-HIAA BY HPLC
K952817 · CDA
Bio-Rad
Chemistry · 42d
Cleared Aug 01, 1995
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
K953207 · DCK
The Binding Site, Ltd.
Immunology · 63d
Cleared Jul 31, 1995
BIOABSORBABLE INTERFERENCE SCREW
K943249 · MAI
Instrument Makar, Inc.
Orthopedic · 390d
Cleared Jul 31, 1995
TOTAL CONTACT SEAT RIPPLE SYSTEM
K943433 · IOQ
Numotech, Inc.
Physical Medicine · 381d
Cleared Jul 31, 1995
SLOAN STA-DRI SURGICAL JUMPSUIT
K944118 · LYU
Sloan Corp.
General Hospital · 342d
Cleared Jul 31, 1995
SLOAN STA-DRI BOOTLEG LEGGING
K944276 · LYU
Sloan Corp.
General Hospital · 335d
Cleared Jul 31, 1995
ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES
K945948 · KGO
Ampri Rubberware Industries Sdn Bhd
General Hospital · 237d
Cleared Jul 31, 1995
GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)
K950864 · LZJ
Acu Med, Inc.
Orthopedic · 154d
Cleared Jul 31, 1995
VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM
K951077 · LJT
Med Institute, Inc.
General Hospital · 144d
Cleared Jul 31, 1995
CATHETER, INTRAVASCULAR OR PERCUTANEOUS
K951078 · LJS
Sims Deltec, Inc.
General Hospital · 144d
Cleared Jul 31, 1995
SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM
K951268 · HRX
Spine-Tech, Inc.
Orthopedic · 132d
Cleared Jul 31, 1995
COMFEEL PLUS PRESSURE RELIEF DRESSING
K951325 · FMP
Richard Hamer Assoc., Inc.
General Hospital · 130d
Cleared Jul 31, 1995
MASTERSCREEN PFT BODY
K951901 · JEH
Erich Jaeger GmbH & Co. KG
Anesthesiology · 98d
Cleared Jul 31, 1995
AEROS ASPIRATOR
K952103 · BTA
Aeros Instruments, Inc.
General & Plastic Surgery · 88d
Cleared Jul 31, 1995
IV POLE/STAND
K952196 · FOX
Valentine Intl. , Ltd.
General Hospital · 83d
Cleared Jul 31, 1995
OTOSILK
K952203 · NAD
Boston Medical Products, Inc.
General & Plastic Surgery · 82d
Cleared Jul 31, 1995
BARRIER ALL FILM
K952234 · EFS
Cottrell, Ltd.
Dental · 80d
Cleared Jul 31, 1995
PICC LINE KIT
K952256 · FOZ
Medi-Flex Hospital Products, Inc.
General Hospital · 77d