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
160369–160392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1982
MICROBIOLOGY SPECIMEN BRUSH
K820771 · BTG
Mill-Rose Laboratory
Microbiology · 41d
Cleared May 03, 1982
RESPIRATION MONITOR 1000
K820778 · BZQ
Intl. Medical Devices , Ltd.
Anesthesiology · 41d
Cleared May 03, 1982
CANCAN 2002 DENTAL PATIENT CHAIR
K820789
Time Motion System Co.
Dental · 41d
Cleared May 03, 1982
MEDICAM
K820829 · FWB
M.P. Video, Inc.
General & Plastic Surgery · 39d
Cleared May 03, 1982
CONCHO PEDIATRIC PACK
K820878 · BTT
Rci, Inc.
Anesthesiology · 34d
Cleared May 03, 1982
CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
K820895 · LIN
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 34d
Cleared May 03, 1982
TECA MODEL SENSOR ER 94
K820908 · GWF
Teca, Inc.
Neurology · 32d
Cleared May 03, 1982
RA-1000 SYSTEM ADD'L ANALYTES PHASE III
K820913 · CEK
Technicon Instruments Corp.
Chemistry · 32d
Cleared May 03, 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 27d
Cleared May 03, 1982
SYSTEM I INFANT MONITORING SYS
K820943 · FLS
Burr Engineering & Development Co.
Anesthesiology · 27d
Cleared May 03, 1982
MICROPLATE WASHING DEVICE
K820992 · JTC
Skatron, Inc.
Microbiology · 25d
Cleared May 03, 1982
SALMONELLA & SHIGELLA GROUPING SERA
K820996 · GRL
Fisher Scientific Co., LLC
Microbiology · 24d
Cleared May 03, 1982
ECLIPSE
K821007 · JQW
Scientific Software & Instrument Co.
Chemistry · 24d
Cleared May 03, 1982
ACE ACTIVITY MICROVIAL TEST SET
K821011 · KQN
Ventrex Laboratories, Inc.
Chemistry · 21d
Cleared May 03, 1982
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · BTR
Shiley, Inc.
Anesthesiology · 20d
Cleared May 03, 1982
NOVA II FLUIDS PACK
K821030 · JIX
Shaban Mfg. Co.
Chemistry · 20d
Cleared May 03, 1982
AMERLEX B-LCG RIA KIT
K821031 · JHI
Amersham Corp.
Chemistry · 20d
Cleared May 03, 1982
MODEL SR-1020LF
K821032 · FPA
Stewart-Riess Labs
General Hospital · 20d
Cleared May 03, 1982
SKATRON REPEATING DISPENSER
K821034 · JQW
Skatron, Inc.
Chemistry · 20d
Cleared May 03, 1982
UNI-PUMP 200
K821039 · JQW
Scientific Mfg. Industries, Inc.
Microbiology · 20d
Cleared May 03, 1982
RAPID SST
K821040 · JTO
Mds Laboratories, Inc.
Microbiology · 20d
Cleared May 03, 1982
IVAC 630 & VOLUMETRIC INFUSION PUMP
K821047 · FRN
Y
General Hospital · 19d
Cleared May 03, 1982
LIQUID-STAT TM AST-UV LIQUID ENZUNE
K821048 · CKA
Beckman Instruments, Inc.
Chemistry · 18d
Cleared May 03, 1982
715 DELTA TERMINAL
K821058 · JQP
Corning Medical & Scientific
Chemistry · 18d