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
116713–116736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1992
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA
K922736 · JLW
Eastman Kodak Company
Chemistry · 32d
Cleared Jul 10, 1992
GUEDEL AIRWAY
K922748 · CAE
Oem Medical Div.
Anesthesiology · 32d
Cleared Jul 09, 1992
CARDIO-CARD ECG MANAGEMENT SYSTEM
K920020 · DPS
Nasiff Assoc., Inc.
Cardiovascular · 189d
Cleared Jul 09, 1992
ORIEL
K920272 · HLJ
Truphatek, Ltd.
Ophthalmic · 169d
Cleared Jul 09, 1992
SINGLE-STEP PREGNANCY, HCG TEST
K922290 · JHI
American Medical Products, Inc.
Chemistry · 55d
Cleared Jul 09, 1992
ZIESS ENDOPROBE
K922735 · HQB
Carl Zeiss, Inc.
Ophthalmic · 31d
Cleared Jul 09, 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Jul 08, 1992
HYPOTRANS MODEL 750
K911577 · KDK
Martin Mclane Medical
Gastroenterology & Urology · 457d
Cleared Jul 08, 1992
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183 · DTQ
3M Health Care, Sarns
Cardiovascular · 233d
Cleared Jul 08, 1992
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
K915312 · CBK
Puritan Bennett Corp.
Anesthesiology · 229d
Cleared Jul 08, 1992
TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO
K920702 · LGD
Pharmacia Diagnostics, Inc.
Microbiology · 141d
Cleared Jul 08, 1992
ZEISS MULTI YAG LASER
K920967 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 128d
Cleared Jul 08, 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199 · EMX
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 118d
Cleared Jul 08, 1992
MICROLINE SCREEN FOR PHENCYCLIDINE
K921651 · LCM
Drug Screening Systems, Inc.
Toxicology · 93d
Cleared Jul 08, 1992
PATIENT EXAMINATION GLOVES
K921799 · LYY
Consolex Corp. Sdn. Bhd.
General Hospital · 89d
Cleared Jul 08, 1992
CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER
K921842 · GEX
Cynosure, Inc.
General & Plastic Surgery · 82d
Cleared Jul 08, 1992
LUMINOUS 250 FIBEROPTIC ILLUMINATOR
K921866 · HBI
Progressive Dynamics, Inc.
General & Plastic Surgery · 79d
Cleared Jul 08, 1992
GRICE LAPAROSCOPIC SUTURING NEEDLE
K921922 · GCJ
Ideal Medical, Inc.
General & Plastic Surgery · 76d
Cleared Jul 08, 1992
O BUTMENT HB
K921933 · DZE
"O" Co., Inc.
Dental · 75d
Cleared Jul 08, 1992
EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG
K922375 · GEX
Excel Tech. , Ltd.
General & Plastic Surgery · 49d
Cleared Jul 07, 1992
SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM
K920294 · LOS
Stuart Medical, Inc.
Cardiovascular · 167d
Cleared Jul 07, 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
K920636 · JJY
Baxter Diagnostics, Inc.
Chemistry · 146d
Cleared Jul 07, 1992
EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200
K920765 · DXH
Electronic Monitoring Devices, Inc.
Cardiovascular · 139d
Cleared Jul 07, 1992
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
K921558 · GZB
Medtronic Vascular
Neurology · 97d