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
101761–101784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1995
SAS SALMONELLA H C ANTISERUM
K952288 · GRM
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 25, 1995
THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM
K952563 · GCT
The Tulip Mfg. Co.
Gastroenterology & Urology · 53d
Cleared Jul 25, 1995
XENON LIGHT SOURCE MODEL 5121
K952696 · GCT
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 42d
Cleared Jul 25, 1995
HUMID-VENT TRACH-VENT
K952845 · BYD
Gibeck, Inc.
Anesthesiology · 34d
Cleared Jul 24, 1995
FLEXIFLO QUANTUM ENTERAL PUMP
K944669 · FRN
Abbott Mfg., Inc.
General Hospital · 314d
Cleared Jul 24, 1995
LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER
K950498 · KXO
Graphic Controls Corp.
Obstetrics & Gynecology · 168d
Cleared Jul 24, 1995
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER...
K950914 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 151d
Cleared Jul 24, 1995
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
K951071 · KRZ
Alko Diagnostic Corp.
Hematology · 138d
Cleared Jul 24, 1995
REUNION BONE SCREW SYSTEM
K951389 · HWC
Smith & Nephew Richards, Inc.
Orthopedic · 119d
Cleared Jul 24, 1995
IMAGYN HYSTEROSCOPE
K952033 · HIH
Imagyn Medical, Inc.
Obstetrics & Gynecology · 84d
Cleared Jul 24, 1995
LORAD STEROLOC II
K952210 · IZH
Lorad Corp.
Radiology · 75d
Cleared Jul 24, 1995
HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE
K952530 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 53d
Cleared Jul 24, 1995
MULTIDEX GEL
K952774 · MGQ
Lange Medical Products, Inc.
General & Plastic Surgery · 38d
Cleared Jul 24, 1995
DELPORE SKIN CLOSURE
K952947 · FPX
Bitco Intl.
General & Plastic Surgery · 28d
Cleared Jul 24, 1995
MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
K953161 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 21, 1995
DEEPVISON
K942910 · GCJ
Automated Medical Products Corp.
General & Plastic Surgery · 395d
Cleared Jul 21, 1995
PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM
K944040 · IYE
S & S X-Ray Products, Inc.
Radiology · 337d
Cleared Jul 21, 1995
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY
K946353 · LLM
Mrl Diagnostics
Microbiology · 203d
Cleared Jul 21, 1995
EPX-310 VIDEO PROCESSOR (ENDOSCOPY)
K950417 · FET
Marks & Murase
Gastroenterology & Urology · 171d
Cleared Jul 21, 1995
DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION
K950695 · MNH
Depuy Motech
Orthopedic · 157d
Cleared Jul 21, 1995
AQUAGEL LUBRICATING JELLY
K951431 · KMJ
Depuy Healthcare
General Hospital · 116d
Cleared Jul 21, 1995
OMNIPULSE-MAX HOLMIUM LASER
K951562 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 108d
Cleared Jul 21, 1995
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
K951802 · DXT
Scimed Life Systems, Inc.
Cardiovascular · 93d
Cleared Jul 21, 1995
CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC...
K951972 · FBO
Cabot Medical Corp.
Gastroenterology & Urology · 85d