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
85153–85176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1999
MEDITRON STETHOSCOPE SYSTEM
K991367 · DQD
Meditron AS
Cardiovascular · 90d
Cleared Jul 19, 1999
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
K991408 · MQG
Thermoquest Corp.
Obstetrics & Gynecology · 88d
Cleared Jul 19, 1999
MR SPECTROSCOPY PACKAGE
K991568 · LNI
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared Jul 19, 1999
SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES
K991700 · MQH
Swemed Lab International AB
Obstetrics & Gynecology · 62d
Cleared Jul 19, 1999
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102,...
K991827 · HIB
Ri Mos. S.R.L.
Obstetrics & Gynecology · 52d
Cleared Jul 19, 1999
CUTE-LITE I LIGHT CURE UNIT
K991863 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 48d
Cleared Jul 16, 1999
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K991403 · LPN
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Jul 16, 1999
GEBAUER'S CHLORIDE FINE NOZZE
K991514 · MLY
Gebauer Co.
Physical Medicine · 77d
Cleared Jul 16, 1999
STAT PROFILE M7 ANALYZER
K991727 · CGL
Nova Biomedical Corp.
Chemistry · 57d
Cleared Jul 15, 1999
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
K983940 · DYB
Adam Spence Corp.
Cardiovascular · 252d
Cleared Jul 15, 1999
PARKER FLEX-TIP TRACHEAL TUBE
K984528 · BTR
Parker Medical Assoc.
Anesthesiology · 206d
Cleared Jul 15, 1999
MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
K990304 · DZE
Astra Tech, Inc.
Dental · 164d
Cleared Jul 15, 1999
E9000 SYSTEM
K990524 · HRX
Linvatec Corp.
Orthopedic · 146d
Cleared Jul 15, 1999
DBSET MULTIDRUG SCREEN TEST KIT
K990681 · DKZ
Ameritek, Inc.
Toxicology · 135d
Cleared Jul 15, 1999
RAPIDONE - OPIATES TEST
K990820 · DJG
American Bio Medica Corp.
Toxicology · 126d
Cleared Jul 15, 1999
RAPIDONE - COCAINE TEST
K990822 · DIO
American Bio Medica Corp.
Toxicology · 126d
Cleared Jul 15, 1999
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS...
K991001 · DRF
Ep Medsystems
Cardiovascular · 112d
Cleared Jul 15, 1999
SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
K991382 · GCJ
Genicon, LC
General & Plastic Surgery · 85d
Cleared Jul 15, 1999
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
K991389 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 85d
Cleared Jul 15, 1999
ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
K991489 · ELW
Harry J. Bosworth Co.
Dental · 78d
Cleared Jul 15, 1999
ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
K991490 · ELW
Harry J. Bosworth Co.
Dental · 78d
Cleared Jul 15, 1999
DYNAREX DRAIN SPONGE
K991694 · KMF
Dynarex Corp.
General & Plastic Surgery · 58d
Cleared Jul 15, 1999
DYNAREX NON-WOVEN SPONGE
K991695 · KMF
Dynarex Corp.
General & Plastic Surgery · 58d
Cleared Jul 15, 1999
N PROTEIN STANDARD UY
K991705 · JIT
Dade Behring, Inc.
Chemistry · 57d