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
129433–129456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1989
THERA-MIST(TM) NEBULIZER, MODEL 30000
K893942 · CAF
Pegasus Research Corp.
Anesthesiology · 89d
Cleared Aug 28, 1989
THERA-MIST HUMIDIFIER
K894000 · BTT
Pegasus Research Corp.
Anesthesiology · 84d
Cleared Aug 28, 1989
WATER PIK(R)
K894015 · EFS
Teledyne Water Pik
Dental · 83d
Cleared Aug 28, 1989
IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599
K894037 · FRN
Y
General Hospital · 83d
Cleared Aug 28, 1989
PUMP-JECT SYRINGE WITH LUER-LOCK
K894041 · FRN
Ziehm International, Inc.
General Hospital · 83d
Cleared Aug 28, 1989
PREMIER-TOTAL HIP
K894051 · LWJ
Intermedics Orthopedics
Orthopedic · 82d
Cleared Aug 28, 1989
VERICORD S3
K894123 · IYE
Philips Medical Systems, Inc.
Radiology · 77d
Cleared Aug 28, 1989
POWER EXAMINATION TABLE MODEL # 411
K894134 · LGX
Midmark Corp.
General Hospital · 76d
Cleared Aug 28, 1989
POWER EXAMINATION TABLE MODEL # 405
K894144 · LGX
Midmark Corp.
General Hospital · 76d
Cleared Aug 28, 1989
CK-MB/LD-1 CONTROL SYSTEM
K894207 · JJT
Boehringer Mannheim Corp.
Chemistry · 70d
Cleared Aug 28, 1989
PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)
K894230 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 70d
Cleared Aug 28, 1989
URIC ACID TEST ITEM NUMBER 65422
K894287 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Aug 28, 1989
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE KIT
K894519 · KLT
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR CARBAMAZEPINE CALIBRATOR KIT
K894520 · DLJ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR PHENOBARBITAL KIT
K894525 · LGQ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 28, 1989
FPR PHENOBARBITAL CALIBRATOR KIT
K894526 · DLJ
Colony Laboratories, Inc.
Toxicology · 39d
Cleared Aug 25, 1989
HOME BLOOD PRESSURE KIT, ANEROID
K884420 · DXY
Yamasu Co. , Ltd.
Cardiovascular · 309d
Cleared Aug 25, 1989
MODEL 5650 OPTIMATE PERSONAL PROGRAMMER
K884522 · KRG
Teletronics, Inc.
Cardiovascular · 302d
Cleared Aug 25, 1989
ADX TM PHENCYCLIDINE
K890688 · LCM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM OPIATES
K890689 · DGJ
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM BARBITURATES
K890690 · DIS
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX TM BENZODIAZEPINES
K890691 · JXM
Abbott Laboratories
Toxicology · 192d
Cleared Aug 25, 1989
ADX AMPHETAMINE/METHAMPHEAMINE
K890692 · DKZ
Abbott Laboratories
Toxicology · 196d