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
142609–142632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1986
NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
K862876 · KOO
Block Drug Company, Inc.
Dental · 30d
Cleared Aug 29, 1986
ALP (OPT) REAGENT
K862905 · CJE
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Aug 29, 1986
SURGICAL VITEX
K862926 · ELE
Jeneric Ind.
Dental · 28d
Cleared Aug 29, 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Aug 29, 1986
PERCU GUIDE I (LOOP TYPE)
K863090 · GDF
E-Z-Em, Inc.
General & Plastic Surgery · 16d
Cleared Aug 29, 1986
BICORD BY QMED
K863091 · HAM
Qmed, Inc.
General & Plastic Surgery · 16d
Cleared Aug 29, 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 29, 1986
THORACIC CATHETER (CHEST DRAINAGE TUBE)
K863142 · GBS
Sheridan Catheter Corp.
General & Plastic Surgery · 14d
Cleared Aug 29, 1986
VACU-GUARD
K863162
Arbor Technologies, Inc.
General & Plastic Surgery · 11d
Cleared Aug 29, 1986
NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
K863201 · GCY
Allergan, Inc.
General & Plastic Surgery · 10d
Cleared Aug 29, 1986
AMIKACIN (FPIA) CALIBRATOR KIT
K863244 · DLJ
Windsor Laboratories, Inc.
Toxicology · 7d
Cleared Aug 29, 1986
AXIOM TROCAR THORACIC CATHETER
K863247 · GBS
Axiom Medical, Inc.
General & Plastic Surgery · 7d
Cleared Aug 29, 1986
CHILD'S ROLLS POWERED WHEELCHAIR
K863250 · ITI
Invacare Corp.
Physical Medicine · 7d
Cleared Aug 28, 1986
CERYX PACEMAKER MODELS 114, 314 & 614
K854790 · DXY
Vitatron Medical BV
Cardiovascular · 272d
Cleared Aug 28, 1986
OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH
K861493 · DTB
Oscor Medical Corp.
Cardiovascular · 128d
Cleared Aug 28, 1986
ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE
K861761 · LPZ
Travenol Laboratories, S.A.
General Hospital · 114d
Cleared Aug 28, 1986
BURDICK DIVISION (E-500)
K861850 · DPS
Mortara Instrument, Inc.
Cardiovascular · 106d
Cleared Aug 28, 1986
SIEMENS-ELEMA (SICARD-P)
K861851 · DPS
Mortara Instrument, Inc.
Cardiovascular · 106d
Cleared Aug 28, 1986
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR
K862464 · DQO
Shiley, Inc.
Cardiovascular · 59d
Cleared Aug 28, 1986
MINIOX 100 PULSE OXIMETER
K862798 · DQA
Catalyst Research Corp.
Anesthesiology · 36d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
K854944 · DAH
Abbott Laboratories
Immunology · 260d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · CZP
Abbott Laboratories
Immunology · 253d
Cleared Aug 27, 1986
I.V. SET WITH AND WITHOUT AIR VENT
K860952 · FPA
Migada, Ltd.
General Hospital · 167d
Cleared Aug 27, 1986
VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT
K861563 · LJS
Vitaphore Corp.
General Hospital · 124d