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
159697–159720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1982
BEACH AMALGAM CARVER
K821785 · EKH
Pacific Dental Corp.
Dental · 19d
Cleared Jul 06, 1982
BEACH SCALERS
K821786 · EMN
Pacific Dental Corp.
Dental · 19d
Cleared Jul 06, 1982
BEACH SURGICAL PLIERS NON-HOOK
K821787 · EJY
Pacific Dental Corp.
Dental · 19d
Cleared Jul 06, 1982
BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT
K821788 · EMJ
Pacific Dental Corp.
Dental · 19d
Cleared Jul 06, 1982
BEACH CURETTE NO. 2 AND NO. 3 T.G.
K821789 · EMS
Pacific Dental Corp.
Dental · 19d
Cleared Jul 06, 1982
BEACH EXCAVATOR'S NO. 1 & NO. 2
K821790 · EKD
Pacific Dental Corp.
Dental · 19d
Cleared Jul 06, 1982
EXTERNAL PULSE GENERATOR - EV4542
K821791 · DTE
American Pacemaker Corp.
Cardiovascular · 19d
Cleared Jul 06, 1982
PIEZON ULTRASONIC SCALER
K821810 · ELC
Healthco, Inc.
Dental · 21d
Cleared Jul 06, 1982
TEM-STIK
K821824 · EMA
Coralite Dental Products, Inc.
Dental · 14d
Cleared Jul 06, 1982
DEGUCAST U
K821832 · EJS
J. Aderer, Inc.
Dental · 14d
Cleared Jul 06, 1982
QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
K821862 · LCA
Kallestad Laboratories, Inc.
Chemistry · 12d
Cleared Jul 06, 1982
ULTRACHEM GLUC-DH
K821867 · LFR
Harleco Diagnostics
Chemistry · 11d
Cleared Jul 02, 1982
FLEET DETECTATEST
K812728 · KHE
C.B. Fleet Co., Inc.
Hematology · 277d
Cleared Jul 02, 1982
MODIFICATION OF THE PERCUTAN-BALLOON
K813355 · DSP
Smec, Inc.
Cardiovascular · 217d
Cleared Jul 02, 1982
SUFACE REPLACEMENT ELBOW
K820957 · JDB
Howmedica Corp.
Orthopedic · 87d
Cleared Jul 02, 1982
METRACO EVOKED POTENTIAL SYSTEM
K821250 · GWL
Metraco, Inc.
Neurology · 63d
Cleared Jul 02, 1982
ELECTRODYNOGRAM SYSTEM
K821255 · KHX
The Langer Group
Physical Medicine · 63d
Cleared Jul 02, 1982
BARD PROTECTIVE BARRIER FILM
K821271 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 60d
Cleared Jul 02, 1982
AS 700 SERIES INFUSION PUMP ADMIN.
K821377 · FPA
Narco Scientific
General Hospital · 53d
Cleared Jul 02, 1982
SERO/TEX MONO TEST
K821386 · KTN
Texas Immunology, Inc.
Immunology · 53d
Cleared Jul 02, 1982
SERO/TEX CRP TEST
K821388 · DCN
Texas Immunology, Inc.
Immunology · 53d
Cleared Jul 02, 1982
DISPOSABLE BLOOD PRESSURE TRANSDUCER
K821416 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 51d
Cleared Jul 02, 1982
MICRO-SURGICAL POWER INSTRUMENT SYS.
K821487 · GFA
Spire Medical, Inc.
General & Plastic Surgery · 45d
Cleared Jul 02, 1982
MEDICOTEST ELECTRODE PASTE
K821539 · GYB
Medicotest, Inc.
Neurology · 39d