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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124513–124536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1990
SELECTOR ULTRASONIC SURGICAL ASPIRATOR
K901974 · LFL
Spembly Medical , Ltd.
General & Plastic Surgery · 127d
Cleared Sep 05, 1990
MANAN BONE BIOPSY NEEDLE
K902177 · GDM
Manan Medical Products, Inc.
General & Plastic Surgery · 113d
Cleared Sep 05, 1990
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
K902220 · DGR
Boehringer Mannheim Corp.
Immunology · 111d
Cleared Sep 05, 1990
SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER
K902349 · FZW
Surgitek
General & Plastic Surgery · 103d
Cleared Sep 05, 1990
THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK
K902546 · FXX
Anago, Inc.
General Hospital · 89d
Cleared Sep 05, 1990
THE PROTECTOR II, LASER SURGICAL MASK
K902547 · FXX
Anago, Inc.
General Hospital · 89d
Cleared Sep 05, 1990
MODIFICATION OF SEROCARD RUBELLA IGG TEST
K902571 · LFX
Disease Detection International, Inc.
Microbiology · 90d
Cleared Sep 05, 1990
PM GLOVES (MFG: BJL GLOVE (M) SDN.BHD.)
K902670 · LYY
Pm Gloves, Inc.
General Hospital · 79d
Cleared Sep 05, 1990
N-DEX
K902696 · LYY
Moss Point Glove Co.
General Hospital · 78d
Cleared Sep 05, 1990
SAFETY FIRST
K902708 · LYY
Bright Rubber Industries Private , Ltd.
General Hospital · 77d
Cleared Sep 05, 1990
NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN
K902844 · EJF
Progressive Dental Supply
Dental · 69d
Cleared Sep 05, 1990
PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE
K903140 · BYJ
Puritan Bennett Corp.
Anesthesiology · 50d
Cleared Sep 05, 1990
OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS
K903214 · EJF
Medical Fittings, Inc.
Dental · 44d
Cleared Sep 05, 1990
ESCORT ITC
K903295 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 42d
Cleared Sep 05, 1990
FLOSSIE TOOTHFLOSS
K903712 · JES
Flossie, Inc.
Dental · 22d
Cleared Sep 05, 1990
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · FMC
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 23d
Cleared Sep 05, 1990
STERILE PATIENT EXAMINATION GLOVES
K903756 · LYY
Tillotson Rubber Co., Inc.
General Hospital · 23d
Cleared Sep 05, 1990
AVI MODEL 270CM INFUSION PUMP
K903782 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MICRO 275CM INFUSION PUMP
K903783 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MODEL 400CM INFUSION PUMP
K903785 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MICRO 845 DUAL CHANNEL INFUSION PUMP
K903786 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MODEL 470CM INFUSION PUMP
K903787 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
MODEL RD-1200 RUBY LASER SYSTEM
K903849 · GEX
Charles L. Rose and Co., Inc.
General & Plastic Surgery · 15d
Cleared Sep 05, 1990
QUANTA LITE TM DSDNA
K903898 · LLL
Inova Diagnostics, Inc.
Immunology · 14d