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
171337–171360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1978
BLOOD PRESSURE MODULE
K780571 · DRQ
C-V Monitors Corp.
Cardiovascular · 29d
Cleared May 09, 1978
DCG PREAMPLIFIER MODULE
K780572 · DRR
C-V Monitors Corp.
Cardiovascular · 29d
Cleared May 09, 1978
SHOE COVERS
K780590 · FXP
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 09, 1978
ISOLATION GOWN
K780605 · FYC
Abco Dealers, Inc.
General Hospital · 29d
Cleared May 09, 1978
ULTRASONIC DIAGNOSTIC TRANSDUCER
K780651 · ITX
Hoffrel Instruments, Inc.
Radiology · 20d
Cleared May 09, 1978
STERILE 100% SILICONE FOLEY CATHETER
K780675 · KOD
Medline Industries, Inc.
Gastroenterology & Urology · 15d
Cleared May 09, 1978
STERILE CLOSED SYSTEM
K780676 · KOD
Medline Industries, Inc.
Gastroenterology & Urology · 15d
Cleared May 09, 1978
AIR MASSAGE SYSTEM
K780710 · IRP
Theracom C/O Arent, Fox, Kintner, Plotki
Physical Medicine · 12d
Cleared May 09, 1978
OTOSCOPE SPECULA
K780723 · EPY
Abco Dealers, Inc.
General & Plastic Surgery · 7d
Cleared May 09, 1978
FIGURETRIM
K780730 · ISB
Jay-Mar INternational Enterprises, IN
Physical Medicine · 7d
Cleared May 04, 1978
CBR-T3RIA KIT
K780499 · CDP
Clinical Bioresearch
Chemistry · 37d
Cleared May 04, 1978
BLOOD CULTURE MEDIA
K780615 · JSH
Meda Stat Diagnostics, Inc.
Microbiology · 21d
Cleared May 03, 1978
LYPOPROTEIN CHOLESTEROL TEST KIT
K780173 · JHM
Environmental Chemical Specialties
Chemistry · 90d
Cleared May 03, 1978
HEMO FEC
K780214 · KHE
Boehringer Mannheim Corp.
Hematology · 84d
Cleared May 03, 1978
SHIELD
K780263 · EJK
Lorvic Corp.
Dental · 75d
Cleared May 03, 1978
CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS.
K780372
Abbott Laboratories
Chemistry · 56d
Cleared May 03, 1978
BLOOD PUMP-MODE S10K
K780410 · FIR
3M Health Care, Sarns
Gastroenterology & Urology · 51d
Cleared May 03, 1978
LELECTIVE KINETIC SYSTEM-60
K780464 · JJE
Hycel, Inc.
Chemistry · 42d
Cleared May 03, 1978
KOVA TROL III
K780482 · JJW
Icl Scientific
Chemistry · 37d
Cleared May 03, 1978
CBR-T3 UPTAKE KIT
K780500 · KHQ
Clinical Bioresearch
Chemistry · 36d
Cleared May 03, 1978
CREATINE PHOSPHOKINASE (CPK)
K780504 · JHS
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE
K780505 · CIT
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
CARBON DIOXIDE REAGENTS
K780506 · KMS
Gamma Enterprises, Inc.
Chemistry · 34d
Cleared May 03, 1978
SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
K780507 · CKC
Gamma Enterprises, Inc.
Chemistry · 34d